MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION SCREWDRIVER

Catalog Number	352.311
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part #: 352.311, synthes lot number: 5101120, supplier lot number: (b)(4), release to warehouse date: october 17, 2005, supplier: (b)(6).Although an mrr was generated on (b)(6) 2005, it is unknown if it is relevant to the current complaint of a ¿defective device¿, which is the only information available in (b)(4) as of (b)(6) 2020.The mrr states the non-conformance/findings were cosmetic in nature, with ¿burrs on inner-shaft¿.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the extraction screwdriver was received at us customer quality (cq) with the distal tip of the inner shaft broken.The broken off portion wasn't returned.This agrees with the reported complaint device failure/ defect identified? yes, the inner shaft has a broken tip.Dimensional inspection: the ø 2.0mm of the inner shaft proximal to the break was measured.Outer diameter: ø2.0 +0.1/-0.1 mm, caliper: ca (b)(4), measured diameter = ø 1.98 mm, conclusion: the measuring result does show conformity.No product design issues or discrepancies were observed during this investigation.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new, unique or different patient harms were identified because of this evaluation.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.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) 2020, that the extraction screwdriver was defective.Patient outcome is unknown.Upon investigation findings, this complaint became reportable as a malfunction on (b)(6) 2020.This report involves one (1) extraction screwdriver.This is report 1 of 1 for (b)(4).

• Brand Name: EXTRACTION SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10390106
• Report Number: 8030965-2020-05848
• Device Sequence Number: 3447163
• Product Code: HXX
• UDI-Device Identifier: 07611819790735
• UDI-Public: (01)07611819790735
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/25/2020

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: 352.311
• Device Lot Number: 5101120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1