MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC POSITIONING DEVICE FOR GUIDING BLOCK; GUIDE

Catalog Number	03.108.006
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Date of event: it is unknown when locking mechanism began to stick.Device is an instrument and is not implanted/explanted.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review has been requested.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 checking of the function of the positioning device for guiding block on (b)(6) 2018, it was noticed that the locking device was stuck and not securing the guide block.There was no patient involvement.Concomitant device: guide block (part: unknown, lot: unknown, quantity: unknown).This report is for a positioning device for guiding block.This is report 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.Device history record (dhr) review: part: 03.108.006; lot: 2363090; manufacturing site: bettlach; release to warehouse date: 23 april 2008.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation summary: it was reported on (b)(6) 2018, a positioning device for guiding block was stuck and not securing the guide block during checking of the function of the instrument.Damage: visual (appearance not as expected).Visual inspection: upon visual inspection it was noticed that the cap screw recess was stripped, which could have prevented the device from functioning as intended.Does the received condition agree with the complaint description? the stripped screw would prevent the device from being locked into a specific position as intended, which in turn agrees with the complaint description.Dimensional inspection: considering the complaint condition and the stripped screw, a dimensional inspection does not apply.Document/specification review: relevant design drawing was reviewed and no product design issues or discrepancies were observed.Was the complaint confirmed? yes.Although a definitive root cause could not be determined, the positioning device is over 10 years old, and it is most likely that the screw stripped due to the cumulative effect of routine use over its lifespan.During the investigation no unidentified product design/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.

• Brand Name: POSITIONING DEVICE FOR GUIDING BLOCK
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7903195
• Report Number: 2939274-2018-53921
• Device Sequence Number: 18874147
• Product Code: FZX
• UDI-Device Identifier: 10886982071569
• UDI-Public: (01)10886982071569
• 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,Followup
• Report Date (Section B): 08/30/2018

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: 03.108.006
• Device Lot Number: 2363090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2018