MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRIVING CAP/THREADED; MISC ORTHO SURGICAL INSTR

Catalog Number 03.010.523

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is synthes sales representative the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.A review of the device history records 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 Description

It was reported that on an unknown date, the patient underwent an orthopedic procedure when the hammer impactor broke off at the thread junction inside of the insertion handle.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.Concomitant device reported: radiolucent insertion handle frn (part#: 03.033.001, lot# unknown, quantity 1).This report is for one (1) driving cap/threaded.This is report 1 of 1 for (b)(4).

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.Date of event: exact date of event is unknown; event reportedly occurred in (b)(6).Concomitant medical products: complainant part is no longer expected to be returned for manufacturer review/investigation.Device evaluated by mfr, device manufacture date: the provided part number (03.010.523) and lot number (l750728) combination could not be verified in the records.Review of the device history records was not possible.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.

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.H10 additional narrative: b5; d10 h3, h4, h6: a device history record (dhr) review was conducted: part: 03.010.523,  lot: l759640, manufacturing site: bettlach, release to warehouse date: 19may2018.The device history record shows this lot of 35 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and criteria at the time of release with no issues documented during the manufacturing process.  material 1.4542 was hardened and documented according to specifications  hv10 min.450, max.451 (specified min.423, max.468 hv 10) .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.H3, h6: a product investigation was conducted.Visual inspection: visual inspection performed at customer quality (cq) revealed the driving cap broke at the most proximal thread.The fracture surface appears homogeneous with no voids or abnormalities.The balance of the device shows surface wear consistent with use and which would not impact the functionality.No new issues were identified during this investigation.The received condition agreed with the complaint description.The complaint was confirmed.An insertion handle (03.033.001 lot #: l750728 qty: 1) was returned with the broken piece of the driving cap within its threads.There were no observed defects or failures with the returned concomitant insertion handle.Dhr review: the returned device was manufactured in may 2018.The device history record shows this lot of 35 pieces was processed through the normal manufacturing and inspection operations, including material, with no rework or nonconformities noted.This lot met all dimensional, visual and criteria at the time of release with no issues documented during the manufacturing process.Drawing/specification review: the relevant drawings were reviewed during investigation and no design issues were noted.Dimensional inspection: dimensional inspection conducted at cq at the region proximal to breakage measured 7.77mm that falls within the specification of 7.8mm +/-0.1 mm per se_380067 rev.L.Measured with callipers.Conclusion: the complaint condition was confirmed during investigation.While a definitive root cause could not be identified, it is possible that an off-axis strike on the driving cap contributed to the complaint condition.No product design or manufacturing issues were identified, and no new malfunctions were identified either.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based upon these results, 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 Description

It was further reported that the reported event occurred during intramedullary (im) nail femur procedure.Concomitant device reported: radiolucent insertion handle frn (part#: 03.033.001, lot# l750728 , quantity 1).

• Brand Name: DRIVING CAP/THREADED
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8206359
• MDR Text Key: 131723053
• Report Number: 2939274-2018-55644
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982069351
• UDI-Public: (01)10886982069351
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.523
• Device Lot Number: L759640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1