MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG FEM ADPT TORQUE WRENCH; KNEE INSTRUMENTS

Catalog Number 961673

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).Depuy synthes has been informed that the lot number is not available.If additional information is received, a follow-up medwatch will be filed as appropriate.

Event Description

The femoral adapter torque wrench is missing the black ring.It was removed from the tray.

Manufacturer Narrative

The device associated with the reported event was not returned for evaluation.A search of the complaint database against product code 961673 found additional reports of end cap component breakage.Capa (b)(4) was previously initiated to further investigate sig fem adpt torque wrench protector cap breakage and identify corrective actions.Co (b)(4) has been initiated to change the design of product code 961673 as part of capa (b)(4).The current reported complaint sample has an unknown manufacture date.The investigation could not draw any conclusions about the root cause of the current reported broken protector cap without the instrument and protector cap to examine.Based on the inability to conclusively determine a root cause, a need for corrective action is not indicated.Although this investigation did not establish a need for corrective action, co (b)(4) has been initiated to change the design of product code 961673 as part of capa (b)(4).Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SIG FEM ADPT TORQUE WRENCH
• Type of Device: KNEE INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5955675
• MDR Text Key: 54938721
• Report Number: 1818910-2016-27262
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

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: 961673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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