MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFRAME EXTENSION-ADJUSTABLE; MISC ORTHO SURGICAL INSTR

Catalog Number	387.334
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.The device was 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2019 , the synframe extension with snap in locking was not functioning properly during the procedure.Following the case, the synframe extension was being disassembled and the staff noted that it had jammed.The surgeon tried to straighten up the synframe extension, however, the button was not used to retract to free the synframe extension.The stop broke off when force was applied and the position of the synframe extension cannot be fixed.There was no patient impact and no surgical delay reported.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, h4, h6: a device history record (dhr) review was conducted: part: 387.334, lot: l713158, manufacturing site: haegendorf, release to warehouse date: 03.Apr.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was conducted.Shipped back device ¿synframe-extension w/joint w/snap-in loc¿ with lot number l713158 is in used condition.Signs of damage are present all over the device.Furthermore, the gear teeth, used to stop the position of the device, have been broken.The device is broken and the position of the synframe extension with snap in locking cannot be fixed.For this reason, functional tests cannot be performed.The relevant documents were reviewed: all the documents mentioned above have been analyzed.The manufacturing process was executed according to the analyzed documents and no anomalies were found.According to relevant drawing the component had half a gear with teeth.It is not possible to perform a dimensional inspection on the device because the gear teeth, used to stop the position of the device, have been broken.Hardness was measured on component according to relevant drawing, using hardness tester.The expected hardness value was inside specification, confirming the absence of a hardness issue.Conclusion: the complaint is rated as confirmed as the device is not functional anymore in the current condition.No manufacturing related issue could be identified during the evaluation.Most likely the device was used incorrectly and the mishandling caused damage to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: SYNFRAME EXTENSION-ADJUSTABLE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8771317
• Report Number: 8030965-2019-66085
• Device Sequence Number: 1708545
• Product Code: LXH
• UDI-Device Identifier: 07611819255906
• UDI-Public: (01)07611819255906
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: 387.334
• Device Lot Number: L713158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1