MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-06 for RASP HANDLE FOR CABLE - LOCKED RASPS N/A 00902900101 manufactured by Zimmer Biomet, Inc..
[89422991]
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[89422992]
It was reported that while rasping the ml taper during primary total hip, the tip of the broach handle fractured causing loosening of the spring. The device was deemed the unusable. No pieces were retained in the patient. A second rasp handle was used so the case continued without issue. No patient consequences were reported. No further information has been made available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2017-06822 |
| MDR Report Key | 6925733 |
| Date Received | 2017-10-06 |
| Date of Report | 2018-06-28 |
| Date of Event | 2017-09-11 |
| Date Mfgr Received | 2018-06-25 |
| Device Manufacturer Date | 1998-10-22 |
| Date Added to Maude | 2017-10-06 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RASP HANDLE FOR CABLE - LOCKED RASPS |
| Generic Name | INSTRUMENT, HIP |
| Product Code | HTR |
| Date Received | 2017-10-06 |
| Returned To Mfg | 2017-09-11 |
| Model Number | N/A |
| Catalog Number | 00902900101 |
| Lot Number | 59082200 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-06 |