MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SCREW INSERTER/EXTRACTOR; INSTRUMENT, KNEE

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00598304048 - mis hdegd scr 48mm - unknown.Unknown ppk cut guide - unknown.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00335.

Event Description

It was reported that during a right partial knee replacement, the head of the screw broke off and was stuck in the cut guide.It took about 20 minutes to remove the screw.No consequences or impact to the patient.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Visual examination of the returned product identified the screw had a fracture along the shaft and the hex was fractured.The fractured part of the shaft was also bent.Examination of the screw inserter identified the hex feature exhibited some wear.Dimensional analysis of the hex feature determined that the product, where measured, was conforming to print specifications.Sem analysis of the fractured screw identified ductile overload dimples at the center of the fracture.The fracture surface also showed post fracture damage and debris that obscured the details of crack imitation.Eds elemental analysis of the screw identified the material was consistent with stainless steel.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SCREW INSERTER/EXTRACTOR
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9632870
• MDR Text Key: 186726013
• Report Number: 0001822565-2020-00334
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598304900
• Device Lot Number: 63915520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 05/26/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1