MAUDE Adverse Event Report: SYNTHES HAGENDORF EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS; EXTRACTOR

Catalog Number 357.133

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Manufacturing site: (b)(4).Manufacturing date: november 29, 2006.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this 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.

Event Description

Device report from synthes (b)(6) reported the following event: during a femoral nail removal procedure on (b)(6) 2016, the surgeon was unable to screw the extraction screw into the top of the femoral nail, and had to use different equipment to remove the nail.As a result, there was a fifteen (15) minute delay.The threads of the extraction screw are warped and it is unable to function properly.Patient outcome is unknown.The need for the removal procedure is being captured under linked complaint (b)(4).Concomitant devices reported: 11mm ti lateral entry femoral recon nail / 420mm/rt-sterile (part 04.003.464s, lot 5700198, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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

Update: additional information was received on 01sep2016.No additional medical intervention was required.The procedure was successfully completed.Patient outcome is reported as stable.

Manufacturer Narrative

Reporter name, email address, phone number (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

Additional narrative: 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 a product development investigation was performed for the subject device (extraction screw for ti femoral and tibial nails, part number 357.133, lot number 1585867).The subject device was returned with the complaint condition stating that during a femoral nail removal procedure (captured in (b)(4)) on (b)(6) 2016, the surgeon was unable to screw the extraction screw into the top of the femoral nail, and had to use different equipment to remove the nail.As a result, there was a fifteen (15) minute delay.The threads of the extraction screw are warped and is unable to function properly.No additional medical intervention was required.The procedure was successfully completed.Patient outcome is stable.This complaint is confirmed.The extraction screw was received intact but with the distal tip damaged / stripped.The threads show wear and flattening.The extraction screw was unable to be fully threaded into the returned nail during this evaluation due to the damage.Therefore, the complaint condition was able to be replicated.The damage on the extraction screw is consistent with cross threading.Per the technique guide, bony ingrowth and tissue must be removed from the end of nail prior to inserting the extraction screw into the nail and the nail is to be extracted using ¿gentle blows with the hammer.¿ a visual inspection under 5x magnification, device history record (dhr) review, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.No new, unique or different patient harms were identified as a result of this evaluation.Additionally, the calculated occurrence rate is acceptable with the applicable design and clinical risk management occurrence rate.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.An 11mm ti lateral entry femoral recon nail / 420mm/rt (04.003.464 lot number 5700198) was returned as a concomitant device without an alleged complaint condition.Upon visual inspection there is no evidence that this device contributed to the complaint condition, and therefore no additional investigation will be performed on this device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5916977
• MDR Text Key: 53555628
• Report Number: 3003875359-2016-10467
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/19/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 357.133
• Device Lot Number: 1585867
• Other Device ID Number: (01)10886982195883(10)1585867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 08/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/19/2016; 09/22/2016; 09/27/2016; 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1