MAUDE Adverse Event Report: SYNTHES BETTLACH PFNA Ø9 LONG R 130° L300 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.023.104S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: additional product code: hwc.Device is not distributed in the united states, but is similar to device marketed in the usa (b)(4).Device broke intra-operatively and was not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.The pfna nail broke postoperatively and will require additional surgical intervention to remove the construct.The 510k #unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 on an event in (b)(6) as follows: it was reported that a proximal femoral nail antirotation (pfna) broke postoperatively.Complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(4).Is this a single use device that was reprocessed and reused on a pt?, device available for evaluation? (b)(6).Device history records review was completed for part # 04.023.104s, lot # 9785529.Manufacturing location: (b)(4), manufacturing date: jan 26, 2016.Expiry date: jan 01, 2026.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Corrected data: date of event is unknown.Implant date, explant date.Reporter country.Device 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

Post-operative x-ray also revealed broken locking bolt.Patient outcome is not reported.This is report 1 of 2 for (b)(4).

• Brand Name: PFNA Ø9 LONG R 130° L300 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6068106
• MDR Text Key: 58813767
• Report Number: 9612488-2016-10438
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.023.104S
• Device Lot Number: 9785529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR