MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 SP2EXTRAMED BASE TIB ALIGN DEV; ALIGNMENT DEVICES

Catalog Number	966310
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
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 the tibial cutting guide is stripped.It was also reported that the screw knob that locks the ankle clamp to the up rod is stripped.No surgical delay.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary examination of the returned device 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary examination of the returned device confirms the reported event.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: examination of the returned device 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SP2EXTRAMED BASE TIB ALIGN DEV
• Common Device Name: ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 7133568
• Report Number: 1818910-2017-52181
• Device Sequence Number: 16164506
• Product Code: HWT
• UDI-Device Identifier: 10603295247760
• UDI-Public: 10603295247760
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• 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,Followup,Followup,Followup
• Report Date (Section B): 11/28/2017

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: 966310
• Device Lot Number: H0796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 11/18/2017; 12/20/2017; 12/20/2017; 12/18/2017; 04/04/2018; 04/04/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 12/27/2017; 01/04/2018; 01/04/2018; 04/06/2018; 04/10/2018; 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR