MAUDE Adverse Event Report: SYNTHES GMBH COMPRESSION/DISTRACTION INSTRUMENT; INSTRUMENT, COMPRESSION

Catalog Number	03.111.021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
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.Part: 03.111.021.Lot: t139677.Manufacturing site: (b)(4).Release to warehouse date: 07 november 2016 a review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Subject device has been received and is currently in the evaluation process.No conclusion can be drawn.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 compression/distraction device f/foot+an had the spring and the arm fell apart from the body shaft.The sliding arm and the knob were not received in the evidence provided.A dimensional inspection for the compression/distraction device f/foot+an was unable to be performed due to post manufacturing damage.The observed condition of the device 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 condition of the compression/distraction device f/foot+an 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.Drawing/specifications reviewed the following source controlled drawings reflecting the current and manufactured revisions were reviewed: distractor compact foot.Hauptkoerper komplett mail body complete distractot compact foot (current and manufactured).Arm verschiebbar.Komplett strut translational.Complete distractor compact foot (current and manufactured).Fz fluegelschraube f/vertebral body retainer (current and manufactured).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
Device report from norway reports an event as follows: it was reported that following surgery on (b)(6) 2022, the extractor became dissembled during cleaning in the washing-machine.There was no impact to patient or procedure.Upon manufacturer investigation, it was determined that the compression/distraction device f/foot+an had the spring and the arm fall apart from the body shaft.This report is for a compression/distraction instrument.This is report 1 of 1 for (b)(4).

• Brand Name: COMPRESSION/DISTRACTION INSTRUMENT
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15511848
• Report Number: 8030965-2022-07578
• Device Sequence Number: 20101290
• Product Code: HWN
• UDI-Device Identifier: 07611819375819
• UDI-Public: (01)07611819375819
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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

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: 03.111.021
• Device Lot Number: T139677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2016
• 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