MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN AUTOFIX CANNULATED SCREW 6.5MM; IMPLANT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Disorder (2373)

Event Date 04/01/2014

Event Type  Injury  

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 Description

The manufacturer became aware of a post-market clinical follow-up (pmcf) from hospital of nimes, (b)(6).The title of this report is ¿a post- market clinical follow-up (pmcf) of the treatment of fractures, nonunions, pseudoarthrosis, degenerative changes and corrective osteotomies in small bones with the autofix system¿ which is associated with the stryker autofix system.Within that publication, post-operative complications/ adverse events were reported which occurred between (b)(6) 2014 and (b)(6) 2018.It was not possible to ascertain specific device catalogs 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 21 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses pseudo arthrodesis requiring revision surgery.1 out of 2 cases.The pmcf report states, ¿two patients developed pseudo arthrodesis.This was confirmed when, due to hindfoot pain related to potential pseudo arthrodesis, a ct scan has been performed (earlier than planned, ten months after surgery in both cases).They underwent a new surgery (open surgical revision).In both cases, fixation with 2 new autofix 6.5 mm was achieved using different paths.Now both patients show a good level of consolidation with ratio of fusion superior to 33%.¿.

• Brand Name: UNKNOWN AUTOFIX CANNULATED SCREW 6.5MM
• Type of Device: IMPLANT
• 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: 8922761
• MDR Text Key: 156730097
• Report Number: 0008031020-2019-01110
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention