MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREWS, SELF DRILLING, 2.0X6MM, 5/P; IMPLANT

Catalog Number 50-20596

Device Problem Fracture (1260)

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

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.

Event Description

It was reported that during the removal of the temporary hybrid mmf plates and screws, a 6 mm fractured half way down the screw body (screw fractured during the extraction) and the lower half of screw was removed from patient.The screw pieces were discarded and is not available for return, and no surgical delay occurred.The physician was following procedures and using stryker products as indicated by ifu.No further information is known at this time.

• Brand Name: LOCKING SCREWS, SELF DRILLING, 2.0X6MM, 5/P
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: jonathan schell ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6867031
• MDR Text Key: 86459379
• Report Number: 0008010177-2017-00229
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2017

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: No Information
• Device Catalogue Number: 50-20596
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 09/14/2017
• 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