MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-08 for PAVLIK HARNESS, SMALL 00-1716-010-00 manufactured by Zimmer Surgical.
[28248255]
The device was not returned for evaluation. A review of the device history record (dhr) for lot 24503 noted no relevant issues. Two samples each from current inventory of the 00-1716-010-00 small harness and the 00-1716-011-00 medium harness were evaluated. The buckles were reviewed and compared to the approved sample and no issues were noted. The customer's reported event of poor buckle quality cannot be confirmed. The devices were not returned for analysis. The review of the manufacturing process, dhr and specifications do not indicate any systemic issues. The conditions of the devices or the original shipping containers are unknown. Additionally, the storage conditions and handling process is unknown. Speculating, the most likely cause for the buckles breaking is handling or in transit damage.
Patient Sequence No: 1, Text Type: N, H10
[28248256]
It was initially reported that the buckle on the harness broke and could have seriously hurt the baby. Another device was then checked was also found to be of a very poor standard. Additional clinical information clarified that the baby was put into a harness in (b)(6) 2014 at (b)(6) of age and the problem of the buckle bending out of shape was noted within the first 4 weeks. The buckle got caught in the cellular blanket - when the parent went to lift the baby up, the buckle was pulled out of shape by the traction force of the blanket. The harness was replaced the following day and the baby was placed in a size small pavlik harness and all the buckles were taped down to prevent any distortion. When the tape was removed from around the buckle, the physiotherapist was stabbed by the spears of the right shoulder strap. Blood droplets fell onto and soiled the harness and it had to be removed from the baby. No further issues occurred with the replacement harness. Additional clarification received on 9/7/15 indicated that the issue occurred when the metal capping system that covers the sharp end of the spears at the buckle of the right shoulder strap. The spears had penetrated through the material of the strap, lay exposed to the skin of the child's thorax and the physiotherapist received a stab wound to the left middle finger. There was no injury to the baby reported. There was no medical treatment/intervention given to the physiotherapist. It was stated that the incident was not reported to infection control as the wound was not considered a needle stick or sharps injury and the physiotherapist stated that her tetanus and hepatitis b vaccinations were both up to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526350-2015-00172 |
| MDR Report Key | 5135852 |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-07 |
| Date of Event | 2014-06-01 |
| Date Mfgr Received | 2014-07-07 |
| Date Added to Maude | 2015-10-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNIFER HUTCHISON |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303438801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PAVLIK HARNESS, SMALL |
| Generic Name | PAVLIK HARNESS, SMALL |
| Product Code | IOZ |
| Date Received | 2015-10-08 |
| Catalog Number | 00-1716-010-00 |
| Lot Number | 24503 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-08 |