MAUDE Adverse Event Report: SYNTHES GMBH SCREWDRIVER FOR TI CLICK'X® LOCKING CAP

Catalog Number	388.354
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, part of the screwdriver was bent.There was no patient consequence.This report involves one (1) screwdriver for ti click'x® locking cap.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: reporter is a synthes employee.Part: 388.354, lot: l620750, manufacturing site: (b)(4), supplier: n/a, release to warehouse date: october 18, 2017, expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the complaint device scrdriver f/clickx lockcap self-hold w/t (product code: 388.354, lot number: l620750) was returned to customer quality (cq) west chester for investigation.One of the small protrusions on the device had broken and became deformed.The tip of the device had scratch marks all over the surface.Device/defect identified: yes.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Dimensional inspection: specified dimension: outer diameter of tip.Measured dimension: outer diameter of the tip: conforming.Measuring device used: caliper.Complaint confirmed: the complaint can be confirmed based on the available information.Conclusion: the tip of the item had been damaged and showed signs of device failure.Hence, the complaint was confirmed.A definitive root cause cannot be determined from the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SCREWDRIVER FOR TI CLICK'X® LOCKING CAP
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12845135
• Report Number: 8030965-2021-09655
• Device Sequence Number: 4351356
• Product Code: HXX
• UDI-Device Identifier: 07611819089242
• UDI-Public: (01)07611819089242
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 388.354
• Device Lot Number: L620750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown