MAUDE Adverse Event Report: STRYKER GMBH SR 4MM OFFSET HUMERAL HE AD TRIAL 52X26; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5901-E-5226
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Picture of the device only.
Event or Problem Description
Upon incoming inspection, item was visibly worn.Inner peg was broken off and missing.No further information is available.
Additional Manufacturer Narrative
The reported event that sr 4mm offset humeral he ad trial 52x26 was alleged of 'instruments - broken, deformed, worn or scratched' could be confirmed based on pictures received.More detailed information about the complaint even, such as if the device was used or not, if the device was impacted or not, etc, as well as the affected device must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: the pictures shows that the three holding pegs which can be clipped on and off are indeed either broken off or badly damaged; making the device unusable.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Upon incoming inspection, item was visibly worn.Inner peg was broken off and missing.No further information is available.
Additional Manufacturer Narrative
The reported event that sr 4mm offset humeral he ad trial 52x26 was alleged of 'instruments - broken, deformed, worn or scratched' could be confirmed.Based on investigation, the root cause was attributed to be other related.The failure was caused by to much applied mechanical force which this trial implant had to undergo over the years.The device inspection revealed the following: the entire three-jaw looking chuck is indeed completely broken at its base, making the device unusable.We do believe that to much applied mechanical force which this trial implant had to undergo over the years has finally resulted in the breakage of the three-jaw looking chuck.Note that this device was manufactured in may 2012 (wear and tear over the years).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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Upon incoming inspection, item was visibly worn.Inner peg was broken off and missing.No further information is available.

• Brand Name: SR 4MM OFFSET HUMERAL HE AD TRIAL 52X26
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8217545
• Report Number: 0008031020-2019-00009
• Device Sequence Number: 229380
• Product Code: LXH
• UDI-Device Identifier: 07613327099935
• UDI-Public: 07613327099935
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 04/10/2019

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-E-5226
• Device Lot Number: MAC7K10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/11/2019; 04/10/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/08/2019; 04/10/2019
• 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