MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONICAL EXTRACTION DEVICE FOR THREADED WASHERS; SCRWEDRIVERS

Catalog Number	309.501
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history record has been requested.The investigation could not be completed; 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 the extraction screw is bent out of shape.This case has been reported by the loan kit technician during loan kit inspection.It has been forwarded to depuy engineering for assessment.No further information can be obtained as the case was not reported by the customer.Patient status/ outcome / consequences are unknown and unknown if other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision was required).This complaint involves one (1) device.This report is 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.There are signs of use allover on the surface visible, especially on the threaded tip.Moreover, the device is bent as reported in the complaint description.No other issues were identified on the device.The complaint condition is confirmed as the device is bent.After a visual inspection per guidance provided it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.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.Device history lot part # 309.501.Synthes lot # 7571779.Supplier lot # na.Release to warehouse date: 07 apr 2014.Manufactured by synthes jennersville.No ncr's were generated during production.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.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: CONICAL EXTRACTION DEVICE FOR THREADED WASHERS
• Common Device Name: SCRWEDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8889270
• Report Number: 8030965-2019-67173
• Device Sequence Number: 13530717
• Product Code: HXX
• UDI-Device Identifier: 07611819086081
• UDI-Public: (01)07611819086081
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 07/18/2019

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: 309.501
• Device Lot Number: 7571779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/13/2019
• Patient Sequence Number: 1