MAUDE Adverse Event Report: SYNTHES GMBH SCRDRIVER SHAFT T8 SELF-HOLD; SCREWDRIVER

Catalog Number 314.467

Device Problem Material Twisted/Bent (2981)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j employee.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022, the patient underwent the removal surgery with the screwdriver shaft.The removal surgery was postoperative surgery for the first metatarsal fracture surgery.During the surgery, the screw was not removed with the screwdriver shaft in question.The surgeon used another screwdriver shaft which was prepared for another surgery and succeeded to remove the screw.The surgery was completed successfully within 30 minutes delay.After the surgery, it was confirmed that the tip of the screwdriver shaft was worn and had a rounded shape which seemed to cause the difficulty of removing the screw.The surgeon requested to report inspection status at the time of shipment and the cause of this event.No further information is available.Concomitant device involves unk - screws: trauma(unknown lot number- unknown product code).This complaint involves one(1) devices scrdriver shaft t8 self-hold.This is report 1 of 1 for complaint (b)(4).

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.H10 additional narrative: h3, h4, h6 investigation summary.¿the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the tip of scrdriver shaft t8 self-hold has stripped.No other problem was reported.The observed condition was consistent as an end of life indicator for the device.No other issues where identified.After a visual inspection per guidance provided in windchill document, it was determined that the reusable instrument device was worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.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 stripped of scrdriver shaft t8 self-hold would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.¿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: yes.Device history manufacturing location: supplier - universal punch / inspected, packaged and released by: monument.Release to warehouse date: 14-apr-2020.Part number: 314.467, stardrive screwdriver shaft t8 105mm.Lot number: 27p8008 (non-sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of compliance supplied by universal punch dated (b)(6) 2020 and certificate of tests supplied to universal by carpenter dated (b)(6) 2018 were reviewed and determined to be conforming.Hardness specified at hrc 52 minimum; hardness certified at hrc 53.74 packaging label logs (pll) were reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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: SCRDRIVER SHAFT T8 SELF-HOLD
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14475167
• MDR Text Key: 292501905
• Report Number: 8030965-2022-03425
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819775459
• UDI-Public: (01)07611819775459
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

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: Health Professional
• Device Catalogue Number: 314.467
• Device Lot Number: 27P8008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1