MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT STEP WEDGE SZ3 10MM

Catalog Number	129456131
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that while attempting to assemble the wedge to tray, the tip of the wobble bit was broke off.Surgical delay- 1 minute.Doe: (b)(6) 2017.
Additional Manufacturer Narrative
(b)(4).Investigation summary = > examination of the returned device confirms the reported event.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.Device history lot = > product code 129456131, lot number 167812 device history review = > review of the device history records did not reveal any related manufacturing deviations or anomalies.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT STEP WEDGE SZ3 10MM
• Common Device Name: MBT STEP WEDGE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7125180
• Report Number: 1818910-2017-51881
• Device Sequence Number: 16506533
• Product Code: NJL
• UDI-Device Identifier: 10603295026723
• UDI-Public: 10603295026723
• Combination Product (Y/N): N
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 129456131
• Device Lot Number: 167812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR