MAUDE Adverse Event Report: SYNTHES GMBH T-HANDLE BALL HEX SCREWDRIVER 8MM

Catalog Number	03.010.517
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: 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 or Problem Description
It was reported that on (b)(6) 2022, during an unknown procedure, the screwdriver tip broke off during release of the connecting screw to remove the insertion handle.The spherical hexagonal tip of the screwdriver remained in the connecting screw and could not be removed.The surgeon decided to cut off the insertion handle with a cylindrical burr to release the insertion handle from the nail.Fragments were generated from the distal threaded part of the connecting screw.There was a surgical delay of one (1) hour.The procedure was successfully completed.This report is for one (1) t-handle ball hex screwdriver 8mm.This is report 1 of 1 for (b)(4).
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.H3, h6: the subject device has been received, the investigation is in progress, 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.
Event or Problem Description
This is report 1 of 2 for (b)(4).
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.H10 additional narrative: b5 h3, h6: part number: 03.010.517 lot number: 33p2612 manufacturing site: haegendorf release to warehouse date: february 12, 2020 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device and the returned photos.Visual analysis of the returned sample revealed that scrdriver-hex ø8 w/t-handle w/spheric-he had the distal tip broken off.The tip was returned separately and not inside of the connecting screw.A dimensional inspection was performed for the scrdriver-hex ø8 w/t-handle w/spheric-he and met specifications.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended and/or excessive 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 condition of the scrdriver-hex ø8 w/t-handle w/spheric-he would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: T-HANDLE BALL HEX SCREWDRIVER 8MM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13586838
• Report Number: 8030965-2022-01088
• Device Sequence Number: 17245855
• Product Code: HXX
• UDI-Device Identifier: 07611819499133
• UDI-Public: (01)07611819499133
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 03.010.517
• Device Lot Number: 33P2612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 02/28/2022; 05/03/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/28/2022; 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONNECSCR F/INSERTION HANDLE; INSERT-HANDLE HYBRID; TFNA FEM NAIL Ø10 R 130° L340 TIMO15
• Patient Age: 86 YR
• Patient Sex: Female