MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM / TI CANN FRN / PF 380MM / LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.033.039S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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 a patient underwent revision on (b)(6) 2019 and the titanium cannulated femoral recon nail (frn) was removed due to breakage and possibly delayed healing.It broke at the distal tip of the nail where the anterior-posterior (ap) screw hole is (no malfunction of the screw) and a retrograde femoral nail was implanted.The frn was originally implanted to the patient on (b)(6) 2018.There were a surgical delay of thirty (30) minutes to retrieve the distal end of the broken nail.Procedure was successfully completed.Broken implant removed.Retrograde femoral nail implanted.Patient outcome was good.Concomitant medical products reported: unknown screw (part # unknown, lot # unknown, quantity 2).This complaint involves one (1) 10mm femoral recon nail.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 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.
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.Lot number no valid lot number provided, ce0123 is the number of the notified body in the eu and 776360 is incomplete and incorrect as a wild card search in the erp system did bring no result.Therefore no dhr review by synthes gmbh possible, a device history review could not be performed as the lot number could not be determined from the supplied image(s).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
Updated event description: it was reported that a patient underwent revision on (b)(6) 2019, the titanium cannulated femoral recon nail (frn) was removed due to breakage and possibly delayed healing.It broke at the distal tip of the nail where the anterior-posterior (ap) screw is(no malfunction of the screw) and a retrograde femoral nail was implanted.The frn was originally implanted to the patient on (b)(6) 2018.There were a surgical delay of thirty (30) minutes to retrieve the distal end of the broken nail.Procedure was successfully completed.Patient outcome was good.
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.Investigation summary updated event description: it was reported that a patient underwent revision on (b)(6) 2019, the titanium cannulated femoral recon nail (frn) was removed due to breakage and possibly delayed healing.It broke at the distal tip of the nail where the anterior-posterior (ap) screw is(no malfunction of the screw) and a retrograde femoral nail was implanted.The frn was originally implanted to the patient on (b)(6) 2018.There were a surgical delay of thirty (30) minutes to retrieve the distal end of the broken nail.Procedure was successfully completed.Patient outcome was good.The implant was not returned and instead will be do based on the supplied image from the attachments (5 images from the 5 attachments located in notes & attachments section of the product complaint) was reviewed and the complaint condition for broken could be confirmed as the image(s) showed that only the the nail broken at the location of the second distal screw.As the implant was not returned an as received, dimensional, material or drawing reviews are not applicable.A device history review could not be performed as the lot number could not be determined from the supplied image(s).No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot no valid lot number provided, ce0123 is the number of the notified body in the eu and 776360 is incomplete and incorrect as a wild card search in the erp system did bring no result.Therefore no dhr review by synthes gmbh 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.

• Brand Name: 10MM / TI CANN FRN / PF 380MM / LEFT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8437242
• Report Number: 2939274-2019-57048
• Device Sequence Number: 16593295
• Product Code: HSB
• UDI-Device Identifier: 10886982270900
• UDI-Public: (01)10886982270900
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.033.039S
• Device Catalogue Number: 04.033.039S
• Device Lot Number: 766360
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019; 02/25/2019; 04/10/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 03/20/2019; 04/10/2019; 04/12/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 111