MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 3MM, 80 X 10MM; PIN, FIXATION, THREADED

Catalog Number	50381080
Health Effect - Clinical Code	Irritation (1941)
Date of Event	03/01/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.Based on the investigation results, no definitive relation could be established between the product and the reported failure adverse consequence.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information will be provided.If further relevant information becomes available, the investigation will be reevaluated and resubmitted accordingly.Device disposition is unknown.
Event or Problem Description
The manufacturer became aware of a study from (b)(6) hospital, (b)(6).The title of this report is ¿operative treatments compared with nonoperative treatment of displaced midshaft clavicular fractures¿ which is associated with the stryker apex system and plating system.Within that publication, post-operative complications/ adverse events were reported which occurred between march 2012 and may 2015.It was not possible to ascertain specific device lot or patient information from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 28 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses hardware irritation.1 out of 3 cases.

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 3MM, 80 X 10MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8947785
• Report Number: 0008031020-2019-01202
• Device Sequence Number: 19548058
• Product Code: JDW
• UDI-Device Identifier: 07613327091762
• UDI-Public: 07613327091762
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K861766
• 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
• Report Date (Section B): 08/29/2019

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: 50381080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/29/2019
• 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