MAUDE Adverse Event Report: SYNTHES GMBH COMPRESSION/DISTRACTION HOLDING SLEEVE/2.5MM K-WIRE; INSTRUMENT, COMPRESSION

Catalog Number	03.111.023
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date compression distraction pin holders are bent.There was no patient involvement.During manufacturer's investigation of the returned device it was noted that the device was bent.Additionally, a k-wire was unable to detach from the device.This report is for one (1) compression/distraction holding sleeve/2.5mm k-wire this is report 1 of 4 for complaint (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.H11 additional narrative: e3: reporter is a j&j sales representative.H3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.Visual analysis of the returned sample found the device was bent.Additionally, a k-wire was unable to detach from the device.A complete potential cause for this condition cannot be fully established with available information.Surgical technique was reviewed and the following relevant statements were found at page 9 and 10: finger-tighten the holding sleeves.This will fix the device to the kirschner wires.The blue tightening device may be used to achieve a fixation between the holding sleeve and the kirschner wire.Precaution: apart from the blue tightening device, do not use any other instruments to tighten or loosen the holding sleeves as they may cause damage.To remove compression: loosen the holding sleeves first, then open the locking clamps.Note: use the blue tightening device to loosen the holding sleeves.Carefully remove the device.Remove kirschner wires.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was performed trying to disengage mating component and failed due to bent condition.The overall complaint was confirmed as the observed condition of the comp/distraction holding slv/2.5 k-wire would contribute to the complained device issue.Based on the investigation findings, the potential cause cannot be established, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h4, h6: a manufacturing record evaluation was performed for the finished device: product code # 03.111.023-us lot # 22p9081 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 07-jan-2020 manufacturing site:jabil bettlach 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.H11 additional narrative: corrected: d4 (primary udi number) 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
Additional information received states that the holding sleeves were bent and needed replacement.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COMPRESSION/DISTRACTION HOLDING SLEEVE/2.5MM K-WIRE
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 19637266
• Report Number: 8030965-2024-08069
• Device Sequence Number: 8793992
• Product Code: HWN
• UDI-Device Identifier: 10886982072221
• UDI-Public: (01)10886982072221(10)22P9081
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: 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: 03.111.023
• Device Lot Number: 22P9081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 08/21/2024; 09/24/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/09/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2020
• 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
• Patient Sex: Unknown