MAUDE Adverse Event Report: STRYKER GMBH BASEPLATE CENTERING GUID E LEFT; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5901-1101
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
Pilot wire was put through the pilot wire guide during an rsa.Surgeon noticed metal shavings and felt resistance from the guide when putting the wire in.Event was resolved by surgeon not using a guide.Surgical delay of 1 min.
Additional Manufacturer Narrative
Evaluation revealed the pilot wire and the baseplate centering guide left to be the subject products.No further associated products were reported.A physical examination could not be carried out as the items were not available for evaluation (discarded by the customer).A review of the device history records revealed no discrepancies.The items were documented as faultless prior to distribution.During investigation no material, design or manufacturing related issues were found.As the centering guide had been in use for a longer time (manufactured in 2016) we pre-suppose that the device had fulfilled its tasks in former surgeries as intended.Referring to the event description the surgeon felt resistance and metal shavings while putting the pilot wire through the baseplate centering guide.Most likely the pilot wire got cold welded due to friction based on bending forces during drilling the wire through the guide reception.This is a known reaction and already investigated in previous complaints.To guarantee a correct insertion it is necessary to insert the pilot wire through the guide with axial forces only; bending could lead to fretting and cold welding.With available information a deficiency of the devices could not be verified.The file will be closed formally.In case relevant clinical information or the items should become available, we reserve the right to update the investigation and change the root cause.
Event or Problem Description
Pilot wire was put through the pilot wire guide during an rsa.Surgeon noticed metal shavings and felt resistance from the guide when putting the wire in.Event was resolved by surgeon not using a guide.Surgical delay of 1 min.

• Brand Name: BASEPLATE CENTERING GUID E LEFT
• Common Device Name: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7065388
• Report Number: 0008031020-2017-00670
• Device Sequence Number: 1450019
• Product Code: KWS
• UDI-Device Identifier: 07613327100211
• UDI-Public: 07613327100211
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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: 5901-1101
• Device Lot Number: P16E24
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 99