MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL; APPLIANCE, FIXATION, NAIL

Model Number	394.85
Medical Device Problem Codes	Crack (1135); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: lxt.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records 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 on (b)(6) 2018, during a pelvic surgery, the external fixator bar would not fit into a clamp as expected, as the end of the bar was cracked.A different bar was used to complete the procedure.There were no surgical delay or patient consequence reported.Concomitant device: external fixation clamp ¿ large (part: unknown, lot: unknown, quantity: 1).This report is for a large external fixator 11mm carbon fiber rod 300mm / mr-conditional.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: device history record (dhr) review: item: 394.85; lot: 7751881; rec'd qty: 1650; rec'd date: (b)(6) 2014; manufacturer: quintus, inc.Product purchased complete from quintus with inspection and packaging in monument.Product was inspected and passed per inspection sheet.Certificate of conformance received from quintus, inc indicating that product was manufactured to indicated requirements.No nonconformances (ncs) or reworks were generated during the manufacture of this lot.No nonconformance records (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.Investigation summary: customer quality investigation: the following investigations were performed: damage: visual appearance not as expected.Device condition: visual inspection performed at customer quality (cq) on the given device image showed that external fixator bar cracked at one end.No issues were observed on other portions of the device.The given complaint condition is consistent with the device images provided 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, and no design issues were identified.Dimensional inspection was not able to be performed as the device was not returned.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.Product was inspected and passed per inspection sheet and certificate of conformance received from quintus, inc indicates that product was manufactured to indicated requirements.No ncrs were generated during production.Furthermore, with the given age of device (over 4 years) there is no indication that the device material could have contributed to the complaint condition.Therefore, no design and manufacture issues were identified that would contribute to complaint condition.Conclusion: a definitive root cause for the device cracking could not be determined from the provided information.However, it is likely that any unintended excessive forces during handling such as unintended dropping could have contributed to this complaint condition.The overall complaint condition is confirmed; however, 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.

• Brand Name: LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7703531
• Report Number: 2939274-2018-52980
• Device Sequence Number: 2771000
• Product Code: KTT
• UDI-Device Identifier: 10886982199904
• UDI-Public: (01)10886982199904
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122455
• 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,Followup
• Report Date (Section B): 06/29/2018

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 Model Number: 394.85
• Device Catalogue Number: 394.85
• Device Lot Number: 7751881
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/28/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2018