MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR RETROGRADE STANDARD LOCKING; GUIDE

Catalog Number	03.010.050
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Initial reporter is synthes sales consultant.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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 an unknown procedure on an unknown date, the 4.2mm drill bit was hitting the nail when drilling for the targeted distal interlock.Surgeon was able to pass the drill bit through, but it still hit the nail.No patient consequence or surgical delay was reported.This report is for one (1) aiming arm for retrograde standard locking this is report 2 of 2 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.Date of report /date rec¿d by mfr : initially reported as may 04, 2018, but should be may 05, 2018.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 procedure on (b)(6) 2018, the long drill bit was hitting the nail when drilling for the targeted distal interlock.The surgeon was able to pass the drill bit through, but it still was hitting the nail.The procedure was successfully completed.There was a two-five (2-5) minute surgical delay.The patient was stable.There was no patient consequence reported.
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.A device history record (dhr) review was conducted for part no.: 03.010.050, lot no.: 1911585: manufacturing location: haegendorf, release to warehouse date: 07.Jul.2008: no non-conformance reports (ncrs) were generated during production.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 condition.A product investigation was conducted.Flow: device interation/functional: visual inspection: the device (part 03.010.050, lot 1911585, mfg 07.Jul.2008) was received at us cq with no visible signs of use or damage.Functional test: the aiming arm was able to assemble with mating insertion handle, however a full functional test could not be performed as full intraoperative conditions could not be recreated due to all mating devices not being returned.The complaint was not able to be replicated therefor the complaint does not agree with complaint condition.Dimensional inspection: dimensional analysis was completed, the diameter of the bores were measured using gauge pins.The proximal bore and the distal bore measured and is within specification based on the relevant drawing.Document/specification review: relevant drawing(s) was reviewed.Conclusion: the complaint condition is unconfirmed as the aiming arm was received within specification.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the reported misalignment was due to operational context.No new malfunctions were observed during the course of 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.

• Brand Name: AIMING ARM FOR RETROGRADE STANDARD LOCKING
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7541536
• Report Number: 2939274-2018-52300
• Device Sequence Number: 1818112
• Product Code: FZX
• UDI-Device Identifier: 10886982067227
• UDI-Public: (01)10886982067227
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2018

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: 03.010.050
• Device Lot Number: 1911585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 05/25/2018; 06/28/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 05/30/2018; 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR