MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR LATERAL PLATE VARIAX CLAVICLE 7 HOLE / LEFT; PLATE, FIXATION, BONE

Catalog Number	628207
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device disposition unknown.
Event or Problem Description
Clavicle revision case; revision was due to previous plate and screws pulling out from bone.Surgeon believes this was due to the patient 'lifting weights' in the gym earlier than advised after surgery.Revision case went according to plan with no issues encountered.
Additional Manufacturer Narrative
Correction: h6 (conclusion).Additional information added to section b5.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence provided despite multiple attempts.Based on the given information, the root cause was attributed to be patient related.The failure was caused as the patient was not compliant.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.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
Clavicle revision case; revision was due to previous plate and screws pulling out from bone.Surgeon believes this was due to the patient 'lifting weights' in the gym earlier than advised after surgery.Revision case went according to plan with no issues encountered.Patient was compliant and in a sling for 2 months.Patient is also a heavy smoker and went back to work as a concreter after 2 months post case.

• Brand Name: SUPERIOR LATERAL PLATE VARIAX CLAVICLE 7 HOLE / LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8839396
• Report Number: 0008031020-2019-00945
• Device Sequence Number: 19208601
• Product Code: HRS
• UDI-Device Identifier: 07613252442325
• UDI-Public: 07613252442325
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K113760
• 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): 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 628207
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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: Required Intervention
• Patient Age: 22 YR