MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN REMOTION WRIST CARPAL SCREW IMPLANT

Catalog Number UNK_SEL

Device Problem Material Disintegration (1177)

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

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in the (b)(6).Concomitant medical products: medical product: exceed abt e1 muller cup 36x58, catalog #: ep-123658, lot #: 2135460; medical product: 36mm cocr mod hd std, catalog #: 11-363662, lot #: 266170.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00271, 0001825034 -2019 -01089.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

The manufacturer became aware of a study from (b)(6).The title of this study is (b)(6) and is associated with the remotion total wrist system.Within that publication, post-operative complications/ adverse events were reported, which occurred between 2009 and 2015.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 30 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses lysis.20 out of 22 cases.

• Brand Name: UNKNOWN REMOTION WRIST CARPAL SCREW IMPLANT
• 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: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8415713
• MDR Text Key: 138642603
• Report Number: 0008031020-2019-00272
• Device Sequence Number: 1
• Product Code: JWJ
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2019
• 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): Other