MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.5MM AWL WITH SLEEVE NOMINAL ANGLE; INTERVERTEBRAL FUSION DEVICE

Catalog Number	03.647.990
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Investigation summary: investigation selection: investigation site: (b)(4), selected flow: visual.Visual inspection: besides some wear and tear signs at the tip, the condition of the device is good.Moreover the spring is missing as reported.The received devices could be disassembled and reassembled without difficulty.All features related to the reported complaint condition were reviewed and no other issues were identified.Document/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.As indicated in the manufacturing documents, the device was inspected to 100% before the part left manufacturing site, see also inspection sheet.Dimensional inspection: dimensional analysis could not be performed as the relevant spring is not available for investigation.Conclusion: our investigation has shown that the complaint condition is confirmed due to the missing spring.Unfortunately we are not able to determine the exact cause of this occurrence as no detailed clinical information is provided.By the evidence, that the device passed our 100% final inspection before the device left the manufacturing site we confirm that the cause of failure is not due to any manufacturing non-conformance's.The spring got most likely lost during and/or after sterilization process where the device got disassembled due to cleaning reasons.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 history lot: part number: 03.647.990, lot number: 1l30007, manufacturing site: (b)(4), release to warehouse date: 11.Jan.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 an unknown date a loan kit technician, during loan kit inspection, discovered that an awl with sleeve spring has come away from the awl shaft.No patient involved.This complaint involves one (1) 2.5mm awl with sleeve nominal angle.This is report 1 of 1 for (b)(4).

• Brand Name: 2.5MM AWL WITH SLEEVE NOMINAL ANGLE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9220941
• Report Number: 8030965-2019-69530
• Device Sequence Number: 2184014
• Product Code: OVE
• UDI-Device Identifier: 07611819498099
• UDI-Public: (01)07611819498099
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112068
• 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): 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.647.990
• Device Lot Number: 1L30007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1