MAUDE Adverse Event Report: STRYKER GMBH PEG ALIGNMENT SOUND; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5901-1038
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Glenoid sound peg broke off in patient glenoid.The delay was an extra 15 mins of surgery getting the broken peg out.
Additional Manufacturer Narrative
The reported event that peg alignment sound was alleged of 'implant - breakage / deformation - other' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by possible inadequate positioning also using too much force during the pegged glenoid preparation.The device inspection revealed the following: one peg of the returned peg alignment sound is indeed completely broken out (damaged weld).Unfortunately we are not able to clearly determine the exact cause which has led to this breakage but please keep in mind that this device was manufactured in jan 2015 and is therefore several years in use.The stage of the instrument shows this (wear and tear evident).We do suspect that too much force was applied during positioning / seating (possible excessive impaction).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
Glenoid sound peg broke off in patient glenoid.The delay was an extra 15 mins of surgery getting the broken peg out.

• Brand Name: PEG ALIGNMENT SOUND
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8062204
• Report Number: 0008031020-2018-00977
• Device Sequence Number: 13848578
• Product Code: LXH
• UDI-Device Identifier: 07613327099423
• UDI-Public: 07613327099423
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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: 5901-1038
• Device Lot Number: NW164220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR