MAUDE Adverse Event Report: INTEGRA YORK, PA INC. LEWIN BONE HOLD CLAMP 7; N/A

Catalog Number 225175

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

On 9/28/2017 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - the instrument has not been returned, the investigation is based on the picture supplied in the parent record.Device history evaluation - dhr review nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable.Engineering change order/manufacturing change order history.Corrective action preventive action history/corrections: none.Health hazard evaluation history: none.Conclusion: there was one picture supplied to us for this investigation.The picture of the lewin bone hold clamp shows wear.The complaint report of broken has been confirmed; we cannot determine the root cause without the instrument being returned for our investigation.

Event Description

Customer initially reported that the surgeon was using the lewin clamp to clamp down on patients bone and the entire tip broke off once clamped.No patient injury.On 9/21/2017 customer reports device broke during a right total hip arthroplasty, piece retrieved.

Manufacturer Narrative

10/17/17 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis: one lewis bone clamp returned in used condition, showing minimal wear, staining, and broken tip.Without knowing how the bone nail clamp was used or maintained, excess force applied to the tips of the instrument may have led to the tips breaking.This type of damage is typically the result of improper usage.The complaint is confirmed; damaged/worn.Device history evaluation: dhr review: nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history/corrections: none.Health hazard evaluation history: none.Conclusion: the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: LEWIN BONE HOLD CLAMP 7
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6946145
• MDR Text Key: 90312442
• Report Number: 2523190-2017-00091
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

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 Catalogue Number: 225175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 62 YR