MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 PFC* MOD PLUS TORQUE DRIVER; SCREWDRIVERS

Catalog Number	860284
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The following instruments didn¿t function correctly during knee revision surgery.The 860284.Lot unknown -pfc mod plus torque driver didn¿t appear to click at maximum torque causing the wobble bits to fracture.The 961673.Lot so2008134.-adapter torque wrench.The black plastic adapter that positions over the femoral adapter detached from the instrument during tightening.The 217863136.Lot tbjgf.- modified hudson adapter got stuck on one of the mbt reamers.
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Additional narrative: product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7304309
• Report Number: 1818910-2018-54313
• Device Sequence Number: 16738984
• Product Code: HWR
• UDI-Device Identifier: 10603295215868
• UDI-Public: 10603295215868
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 860284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 03/16/2018; 09/19/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 04/02/2018; 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1