MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., 23/28/35MM BIOSTEON SCREW DRIVER; SCREWDRIVER

Catalog Number	234-020-235
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that a screwdriver broke during installation of a resorbable ligamentoplasty screw.A fragment of the screwdriver got stuck in the screw thread and thus remained in the patient's knee.
Additional Manufacturer Narrative
Alleged failure: he customer reported to the director raqa integrations emea "this morning, a stryker screwdriver ref (b)(4) sn2(b)(6) broke during installation of a resorbable ligamentoplasty screw ref (b)(4).A fragment of the screwdriver got stuck in the screw thread and thus remained in the patient's knee." the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force, 2) screw inserted at an angle, 3) incorrect size of screw for tunnel/graft, 4) tap not used before insertion, 5) driver not fully inserted into screw.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that a screwdriver broke during installation of a resorbable ligamentoplasty screw.A fragment of the screwdriver got stuck in the screw thread and thus remained in the patient's knee.

• Brand Name: PKG., 23/28/35MM BIOSTEON SCREW DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 19441831
• Report Number: 0002936485-2024-00437
• Device Sequence Number: 15575071
• Product Code: HXX
• UDI-Device Identifier: 04546540756350
• UDI-Public: 04546540756350
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 234-020-235
• Device Lot Number: 237-011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown