MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MILTEX MALLET 11 16OZ; M10 - ORTHOPEDIC

Catalog Number 27-660

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

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 initially reports device is defective.On (b)(6) 2015 customer reports the head of mallet broke off in use.No one hurt at this time but fear that could happen.

Manufacturer Narrative

On 12/14/2015 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis: a mallet returned in used condition, with (b)(6) 2015 etched into handle.It is noticed there are scratches and dents of varying degrees on the mallet.Evaluation of the mallet shows that the head is securely attached to the handle and the weld is still intact.Due to the wear, tear of the mallet and unable to confirm report.The complaint is unconfirmed; unable to confirm report.Device history evaluation - nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history.Variance authorization / deviation history: there is no applicable variance authorization / deviation history engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: there is no applicable corrective action preventive action history.Health hazard evaluation history: none.Conclusion: the complaint is unconfirmed; unable to confirm report.

• Brand Name: MILTEX MALLET 11 16OZ
• Type of Device: M10 - ORTHOPEDIC
• 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: 5226730
• MDR Text Key: 31570347
• Report Number: 2523190-2015-00121
• Device Sequence Number: 1
• Product Code: GFJ
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 27-660
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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