MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 LONG R 130° L380 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 472.295S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown pfna nail/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Device evaluated by mfr, manufacture date: without a lot number the device history records review could not be completed.Product was not returned.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent revision surgery due to the transverse breakage of an unknown proximal femoral nail antirotation (pfna) nail at the level of the fracture.Initially, the patient had implantation of pfna system for treatment of a subtrochanteric fracture on (b)(6) 2018.During the revision, there was a difficulty in removing the broken fragments.However, all implants were successfully explanted and was replaced with a large locking compression plate (lcp) with 14 holes.There was a surgical delay of two (2) hours and blood loss of about 1350 cc and some complications due to the recovery of nail, longer scar, different approach and reposition fragments.Patient outcome was unknown.(b)(4) will capture the intra-op events, where device caused the surgical delay, blood loss and some complications , while related complaint (b)(4) will capture the post-op events, where an unknown pfna nail had been found to have transverse breakage.Concomitant devices reported: unknown pfna helical blade (part# unknown, lot# unknown, quantity 1) and unknown locking screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) unknown pfna nail.This is report 1 of 1 for complaint (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.The visual inspection found no product issues that could have contributed to the clinical finding.The investigation of the returned part is documented within (b)(4).No product issues that could have contributed to this clinical finding were found.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part: 472.295s lot: l391532 manufacturing site: bettlach release to warehouse date: 10.May 2017 expiry date: 01.May 2027 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional data-b5, d1-d4, d10, g2 g5: device is not distributed in the united states, but is similar to device marketed in the usa.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 (b)(6) 2019, the patient underwent revision surgery due to the transverse breakage of an unknown proximal femoral nail antirotation (pfna) nail at the level of the fracture.Initially, the patient had implantation of pfna system for treatment of a subtrochanteric fracture on (b)(6) 2018.During the revision, there was a difficulty in removing the broken fragments.However, all implants were successfully explanted and was replaced with a large locking compression plate (lcp) with 14 holes.There was a surgical delay of two (2) hours and blood loss of about 1350 cc and some complications due to the recovery of nail, longer scar, different approach and reposition fragments.Patient outcome was unknown.Concomitant devices reported: pfna helical blade (part#04.027.033s, lot#l829197, quantity#1) pfna end caps (part#04.027.000s, lot# l808773, quantity#1) locking screw (part#04.005.532, lot#l385336, quantity#1) locking screw (part#04.005.530, lot#l391310, quantity#1).

• Brand Name: PFNA Ø10 LONG R 130° L380 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8732294
• MDR Text Key: 149128521
• Report Number: 8030965-2019-65712
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 472.295S
• Device Lot Number: L391532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Date Manufacturer Received: 07/11/2019
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L40 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L42 F/NAILS TAN LIGHT GREEN; PFNA BLADE PERF L90 TAN; PFNA END CAP EXTENS. 0 T40 TAN; UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - SCREWS: LOCKING; UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 80