MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2EXTRAMED BASE TIB ALIGN DEV; KNEE INSTRUMENT : ALIGNMENT DEVICES

Model Number	96-6310
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2020
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
It was reported that on (b)(6) 2020 the scrub tech tried putting the tibial ankle clamp from the sigma specialist 2 instruments pan.The clamp would not fit into the cup rod.The instrument was not used on the patient and during the case.The instrument did not break into parts and everything was collected and sent to office.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device was unable to replicate the reported event.Further examination found the set screw was able to adjust as intended without difficulty.The device appeared heavily worn, with significant abrasion marks along the shaft due to repetitive assembly and disassembly over the life of the device.The wear is consistent with normal use and servicing.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.¿.

• Brand Name: SP2EXTRAMED BASE TIB ALIGN DEV
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10277875
• Report Number: 1818910-2020-15922
• Device Sequence Number: 2526648
• Product Code: HWT
• UDI-Device Identifier: 10603295247760
• UDI-Public: 10603295247760
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2020

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 Model Number: 96-6310
• Device Catalogue Number: 966310
• Device Lot Number: H0596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/23/2020; 07/30/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 07/28/2020; 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1