MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PULL REDUCTION INSTRUMENT FOR LISS; GUIDE

Catalog Number	324.033
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: reporter is a synthes employee.Part: 324.033; lot: 2326778; manufacturing site: (b)(4); release to warehouse date: january 09, 2008.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Visual inspection: the visual inspection has shown that approximately 24mm from the tip section is broken off.The broken tip was not returned for evaluation.The shaft of the tension device is bent, and the coupling part shows strongly wear marks.Dimensional inspection: due to the damages, the relevant dimension could not be measured.However, the parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Document/specification review: the material was reviewed, and the value was confirmed to meet the specification with no (relevant) non-conformance noted.The used material was stainless steel 1.4923 as required.Summary: the visual inspection has shown that approximately 24mm from the tip section is broken off.The broken tip was not returned for evaluation.The shaft of the tension device is bent, and the coupling part shows strongly wear marks.This lot was manufactured in january 2008 according to the specification.Based on that, and the condition of the item, a product related issue can be excluded.Based on the provided information, we are not able to determine the exact cause of this complaint.We only can assume that a combination between intense use and mechanical overload during use did lead to breakage.Based on the manufacturing investigation results, we conclude that the cause of failure is not due to any manufacturing non-conformance.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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that during inspection on an unknown date, a pulling device was noticed to have unknown damage.There was no procedure nor patient involvement.Upon manufacturer receipt and investigation, it was determined that the device was broken.This report is for a pull reduction instrument for liss.This is report 1 of 1 for (b)(4).

• Brand Name: PULL REDUCTION INSTRUMENT FOR LISS
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8691721
• Report Number: 8030965-2019-65209
• Device Sequence Number: 1643956
• Product Code: FZX
• UDI-Device Identifier: 07611819221345
• UDI-Public: (01)07611819221345
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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: 324.033
• Device Lot Number: 2326778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1