MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10MM/130 DEG TI CANN TFNA 340MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.055S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter occupation: synthes employee.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 on an unknown date that the pen is broken.The procedure and the patient outcome are unknown.This is report 2 of 2 for pc-(b)(4).

Event Description

Concomitant device reported: locking screw (part # 04.005.528, lot # l639562 & l636226, quantity 2).

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.H4, h4, h6: manufacturing location: monument manufacturing date: 25-jul-2017, expiration date: 01-jul-2027, part number: 04.037.055s, 10mm/130 deg ti cann tfna 340mm/left ¿ sterile, lot number: h407827 (sterile), lot quantity: 6.Component part(s) reviewed: part number: 04.037.942.2, lock prong 130 degree, tfna, bp55, lot number: l434984, lot quantity: 96.Purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h249495, lot quantity: 1,000.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: h387913, lot quantity: 80.Part number:21127, timoagri16.00, bp80, lot number: h217006, lot quantity: 2,087 lbs.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the tfna fem nail dia 12 le130 degree l300 timo15 (p/n: 04.037.251s, lot #: h407827) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was was broken through the walls of the helical blade opening of the nail.There were scratches on the device which have no impact on the functionality of the device.Device failure/defect identified? yes.Dimensional inspection: the outer diameter of both the broken parts of the received device was measured to be within the specification.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed 10mm ti cannulated trochanteric femoral nail-advanced 235 mm ti cannulated trochanteric fixation nail 130 deg.Complaint confirmed? yes, the received device was broken.Hence confirming the complaint.Investigation conclusion the complaint condition is confirmed for the tfna fem nail dia 12 le130 degree l300 timo15 (p/n: 04.037.251s, lot #: h407827).There is no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H6: patient code 3191 used to capture device failure and surgical intervention.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

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.

Event Description

The removal of the broken device required an additional operation.The procedure was successfully completed.

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.

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.H3, h4, h6- the tfna fem nail dia 12 le130 degree l300 timo15 (p/n: 04.037.251s, lot #: h407827) was returned and received at us cq.Upon visual inspection, it was observed that the device was was broken through the walls of the helical blade opening of the nail.There were scratches on the device likely due to the implantation and explantation which have no impact on the functionality of the device.The complaint condition is confirmed for the tfna fem nail dia 12 le130 degree l300 timo15 (p/n: 04.037.251s, lot #: h407827).There is no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Was launched previous to this complaint to investigate tfna nail breakage and associated drill marks/damage at the head element hole/blade aperture.Device history lot manufacturing location: monument manufacturing date: 25-jul-2017, expiration date: 01-jul-2027, part number: 04.037.055s, 10mm/130 deg ti cann tfna 340mm/left ¿ sterile, lot number: h407827 (sterile).This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.942.2, lock prong 130 degree, tfna, bp55, lot number: l434984, part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h249495, part number: 04.037.912.3, tfna lock drive, bp58, lot number: h387913, part number:21127, timoagri16.00, bp80, lot number: h217006.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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/130 DEG TI CANN TFNA 340MM/LEFT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9488672
• MDR Text Key: 185231297
• Report Number: 8030965-2019-71197
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819651272
• UDI-Public: (01)07611819651272
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.055S
• Device Lot Number: H407827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Date Manufacturer Received: 05/29/2020
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN
• Patient Outcome(s): Required Intervention