MAUDE Adverse Event Report: SYNTHES GMBH TRAIGHT TIP T25 DRIVER STANDARD; SCREWDRIVERS

Catalog Number	03.632.400
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
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 (b)(6), 2021, the patient underwent for a surgery to treat spondylolisthesis.During the procedure, the tip of the screwdriver broke off during final screw tightening.All fragments are removed without additional intervention.The procedure was completed without surgical delay.Patient outcome was stable.This complaint involves two (2) devices.This report is for (1) unk ¿ plates.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that tip of scrdrivershaft t25 std straight tip w/he was broken, and broken pieces were also returned no other issues were identified.The dimensional inspection was not performed due to post manufacturing damage.The observed condition of scrdrivershaft t25 td straight tip w/he was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed broken condition of the scrdrivershaft t25 td straight tip w/he.While no definitive root cause could be determined, it is probable that the tip of the screwdriver shaft was broken due to the unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.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.Drawing/specifications reviewed - the following drawing reflecting the current and manufacture revision was reviewed: straight tip t25 driver shaft with hex coupling 03_632_400 rev d/ rev b (current & manufactured) device history lot - part: 03.632.400; lot: 8065595; manufacturing site: hegendorf; release to warehouse date: 24 october 2012; ncr 3168976 was generated during production.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: TRAIGHT TIP T25 DRIVER STANDARD
• Common Device Name: SCREWDRIVERS
• 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: 12626981
• Report Number: 8030965-2021-08646
• Device Sequence Number: 13777061
• Product Code: HXX
• UDI-Device Identifier: 07611819502024
• UDI-Public: 07611819502024
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 03.632.400
• Device Lot Number: 8065595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - LOCKING/SET SCREWS.
• Patient Sex: Unknown