MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-10 for 1.5MM SYSTEM HIGH TORGUE (HT), SD, X-DR, SCR, 5/PK N/A 95-6104 manufactured by Biomet Microfixation.
[183095632]
Zimmer biomet complaint # (b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: unknown screw, catalog number ni. Lot number ni. Report source: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[183095633]
It was reported that while attempting to insert a screw, the screw fractured halfway into the bone. The fractured portion of the screw was not removed and remained in the bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2020-00153 |
| MDR Report Key | 9813130 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-10 |
| 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. LAKESHIA SMOOT |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.5MM SYSTEM HIGH TORGUE (HT), SD, X-DR, SCR, 5/PK |
| Generic Name | ORTHOPEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE |
| Product Code | GWO |
| Date Received | 2020-03-10 |
| Model Number | N/A |
| Catalog Number | 95-6104 |
| Lot Number | 390230 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-10 |