MAUDE Adverse Event Report: SYNTHES SALZBURG 4.9MM TI LOCKING BOLT 40MM; PIN, FIXATION, SMOOTH

Catalog Number 459.400S

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the patient had a proximal femoral nail anti-rotation (pfna) nail implanted on (b)(6) 2014.In (b)(6) 2015, it was noted that the nail was broken.The patient also had some hip pain.The patient did not report a fall prior to this.The nail was shown broken via an x-ray.On (b)(6) 2015, the patient had a revision procedure to remove the pfna nail and implant an expert asian femoral nail (a2fn) recon nail.It was reported the screws were also broken and there was a surgical delay of twenty minutes.The patient¿s condition is reported as stable.This is report 4 of 4 for (b)(4).

Manufacturer Narrative

Event date: unknown.The device history record review was done on the unsterile article / lot number as a post-operative broken nail cannot be associated to a sterility issue.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Additional narrative: event date: unknown ¿ event reported as possibly occurring in (b)(6) 2015 (onset of pain).(b)(6).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.

Manufacturer Narrative

Device initially was not believed to be part of returned devices received on 21april2015; during evaluation of returned product, it was determined part was returned.A product investigation was completed: one locking bolt 459.400 was received intact.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

Device was used for treatment, not diagnosis the complained event was re-evaluated with respect to the reported device, event information and the manufacturing evaluation results.Based on this information, this medwatch report was corrected to more accurately capture the complained event.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Patient height reported as 159cm.(b)(4).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.

• Brand Name: 4.9MM TI LOCKING BOLT 40MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer (Section G): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4706352
• MDR Text Key: 19089793
• Report Number: 3009417901-2015-10015
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK970733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 459.400S
• Device Lot Number: 9035126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 55