MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for SUTURE NEEDLE T-56; 2-0 TICRON 3113-81 manufactured by Davis And Geck.
[4834]
Tip of needle broke off during surgery to repair rotator cuff tear of right shoulder. X-rays disclosed tip lodged in right shoulder of patient. Attempted retrieval of needle tip was unsuccessful. The remaining portion of the needle was inadvertently discarded and is not available for further review. The materiel management department reported the matter to the manufacturer/supplier on 6/11/93. Device labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: invalid data. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6803 |
| MDR Report Key | 6803 |
| Date Received | 1993-07-22 |
| Date of Report | 1993-06-22 |
| Date of Event | 1993-06-10 |
| Date Facility Aware | 1993-06-10 |
| Report Date | 1993-06-22 |
| Date Reported to Mfgr | 1993-06-11 |
| Date Added to Maude | 1993-10-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUTURE NEEDLE |
| Product Code | HAS |
| Date Received | 1993-07-22 |
| Model Number | T-56; 2-0 TICRON |
| Catalog Number | 3113-81 |
| Lot Number | DM 21 |
| Device Expiration Date | 1994-11-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | 01-NOV-92 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6486 |
| Manufacturer | DAVIS AND GECK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-07-22 |