MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SINGLE LOCKING DRILL GUIDE

Catalog Number	387.286
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.It is unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.Reporter is synthes sales consultant.A device history record (dhr) review was conducted for part number: 387.286, lot number: 4413509: date of manufacture: 21-oct-2002, place of manufacture: (b)(4), part expiration date: none, list of nonconformances: material review report.Description of dhr review: there was one (1) ncr generated during production, material review report (mrr).This nonconformance was generated due to 4 out of (b)(4) pieces failing a functional inspection.The 4 pieces were reworked by the supplier and passed subsequent inspections.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.A product investigation was conducted.The following investigations were performed: broken: device condition: visual inspection performed at customer quality (cq) on the returned locking drill guide showed a missing screw that connects the handle to the sleeve portions.Furthermore, the tip portion of the sleeve bushing was observed to be broken.The broken portions were not returned to customer quality.The received device is consistent with the given complaint condition and therefore the complaint condition was confirmed.Dimensional analysis and document/specification review: relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision) were reviewed, and no design issues were identified.Dimensional inspection was not able to be performed due to missing screw component.Furthermore, the broken portions were also not returned to customer quality.Review of the device history record(s) showed that there were no issues during the manufacture of the product that are relevant to complaint condition.Dhr review showed an mrr ((b)(4)) that was generated to address 4 out of (b)(4) devices that are failing functional inspection which is irrelevant to missing screw and broken tip complaint conditions.Furthermore, the 4 devices were observed to be reworked and passed the subsequent inspections.Therefore, no issues were identified that would contribute to this complaint condition.With the age of the device with consistent usage for over 16 years and the device raw material review performed showing no issues with material confirms that there are no indications that the material could have contributed to complaint condition.Conclusion: a definitive root cause could not be determined from the provided information.However, it is likely that any unintended forces encountered by the device during usage/handling could have contributed to this complaint condition.The complaint condition was confirmed, and no product design issues or manufacturing discrepancies were identified during this investigation.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 on (b)(6) 2018 that a single locking drill guide is missing a set screw during a routine inspection.There was no patient involvement.This report is for one (1) single locking drill guide.This is report 1 of 1 for complaint (b)(4).

• Brand Name: SINGLE LOCKING DRILL GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7832862
• Report Number: 2939274-2018-53544
• Device Sequence Number: 2062152
• Product Code: FZX
• UDI-Device Identifier: 10705034770994
• UDI-Public: (01)10705034770994
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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: 387.286
• Device Lot Number: 4413509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1