MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® COUPLING SCREW; MISC ORTHO SURGICAL INSTR

Catalog Number	338.20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.It is unknown when device broke.Device is an instrument and is not implanted/explanted.(b)(6).Reporter email address is unknown.Part: 338.20; synthes lot: 7137829; supplier lot: na; release to warehouse date: january 22, 2013; manufactured by synthes (b)(4); no nonconformance reports (ncr's) were generated during production.The material was reviewed, and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.Review of the device history record(s) (dhr) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Customer quality investigation: the following investigations were performed: broken: visual inspection performed at customer quality observed the returned coupling screw broken at its distal threaded portion.The broken thread portion was returned.No new issues were identified.The complaint description agrees with the complaint condition and the complaint condition was confirmed.Relevant drawings for the returned instrument were examined (both current revision and from the time of manufacture) and no design issues were noted.Dhs/dcs coupling screw.Dimensional check performed on the threaded diameter of the device at the broken region measured the diameter as 3.96 mm (ca-814) that falls within the specifications of 3.838 mm to 3.978 mm and tolerance specified.The review of the device history record(s) showed that there were no issues during the manufacture of this product, including it material and its properties which would contribute to this complaint condition.While no root cause could be determined it is likely that any unintended off-axis forces encountered by the device during usage and any unintended misalignment occurred during screwing could have led to this broken complaint condition.During the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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
It was reported that during a routine inspection of the dynamic hip screw (dhs) system trays on (b)(6) 2018, a crack was discovered in the threads of the dhs/dynamic condylar screw (dcs) coupling screw.There was no procedure or patient involved in this complaint.This report is for a dhs®/dcs® coupling screw.This is report 1 of 1 for (b)(4).

• Brand Name: DHS®/DCS® COUPLING SCREW
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7857078
• Report Number: 2939274-2018-53662
• Device Sequence Number: 11124115
• Product Code: LXH
• UDI-Device Identifier: 10886982193223
• UDI-Public: (01)10886982193223
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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: 338.20
• Device Lot Number: 7137829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1