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

Catalog Number 5901-1101

Device Problems Metal Shedding Debris (1804); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2017

Event Type  malfunction  

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 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.

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 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
• Type of Device: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7065388
• MDR Text Key: 93686681
• Report Number: 0008031020-2017-00670
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327100211
• UDI-Public: 07613327100211
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 5901-1101
• Device Lot Number: P16E24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 12/21/2017
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 99