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

Catalog Number 225175

Device Problems Break (1069); Use of Device Problem (1670)

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

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer's maude report # mw 5055780 states that the md and tech noted the tenaculum instrument was broken at the tip.Unsure whether broken before or after it was used during the surgical procedure of a right total knee.Two mds observed the right knee to see if the piece of the instrument was in the knee, and the instrument was not seen.Patient had xray taken of right knee and no instrument found.No harm reported.

Manufacturer Narrative

On 11/12/2015 integra investigation completed, method: failure analysis, device history evaluation.Results: failure analysis - a clamp was returned in used condition, not showing any unusual markings.The returned clamp is showing wear, a damaged serrated tip, ratchet misaligned, bent tips and a broken tip.During the visual analysis of the instrument it is noticed that the tips are bent as if it was used in a twisting motion.The serrated tips are nicked and the ratchet is misaligned.It is also noticed that the left tip is broken.The damages to the instrument are usually the result of improper usage.Device history evaluation - dhr review was completed with all history available.Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report/nonconforming material report history.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: none.Health hazard evaluation history: none.Conclusion: the complaint report has been confirmed; 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: 5226714
• MDR Text Key: 31336403
• Report Number: 2523190-2015-00120
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2015

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1