MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 11MM/125 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.112S

Device Problem Device Difficult to Maintain (3134)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluated by mfr, manufacture date: the investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient presented to the hospital with hip pain due to fall post - operatively on (b)(6) 2019.Imaging confirmed a medial migration of the proximal lag screw in trochanteric femoral nailing advanced (tfna) nail through the femoral head and into the pelvic region.The patient had significant alcohol and mental health issues and may have been overdoing it regarding his mobilisation post the insertion of the tfna nail.So, there is a possibility that the screw had started to migrate into the pelvis prior to the fall that brought him to the hospital.The patient was originally implanted with tfna system on (b)(6) 2019.A tfna removal was required followed by a hip replacement in which the revision surgery took place on (b)(6) 2019.The procedure was completed successfully and all implants were explanted.The patient was an in-patient until day 15 and it is unclear as to whether the patient was compliant post discharge.There was no general surgical review that was conducted and that there was no intra-abdominal injuries as per surgeon's impression.Also, there was no abnormality discovered (nad) for blood with the patient's urine and stool.The surgeon believes that this occurred as a result of the screw not being locked off correctly at the primary insertion of the tfna nail.There was also no bone trauma and spicules of bone forced into the pelvis when they opened the patient¿s pelvis to remove the screw.The hole on the inner aspect of the pelvis was about 2.5 cm in diameter with no bone spicules visible.Also, the surgeon checked the nail once it was removed from the femur and found that the ¿grub screw¿ / locking screw was not down at the region of the proximal hole where the lag screw would normally be locked off and therefore believes that it was never locked off sufficiently to begin with.It is unknown if there was a surgical delay.Patient and procedure outcome were unknown.Concomitant device/s reported: locking screw ( part# 04.005.528s, lot# 1l76220, quantity 1).This complaint involves two (2) devices.This report is for one (1) 11mm/125 deg ti cann tfna 170mm - sterile.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: a device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 29-aug-2018, expiration date: 01-aug-2028, part number: 04.037.112s, 11mm/125 deg ti cann tfna 170mm- sterile, lot number: h721428 (sterile), lot quantity: 6.Work order traveler met all inspection acceptance criteria.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.Component part(s) reviewed: part number: 04.037.912.2, lock prong, 125 degree tfna, bp55, lot number: l965892 (quantity 3) / l956457 (quantity 3), lot quantity: 190 total (96 and 94).Purchased finished goods travelers met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h571515, lot quantity: 1,000.Work order traveler met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: h697115, lot quantity: 80.Work order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00, bp80, lot number: h681740, lot quantity: 2,887 lbs.Certificate of analysis supplied by metalwerks, inc.Dated 13-jun-2018 was reviewed and determined to be conforming.Lot summary report dated 28-jun-2018 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.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.H6: complained issue could not be replicated and/or confirmed based on the available information (incl.Pictures and/or x-ray¿s), for details see document "(b)(4) - x-ray review from medical safety officer.Pdf" attached to pc level.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 (information or/and material), 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.

• Brand Name: 11MM/125 DEG TI CANN TFNA 170MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8720270
• MDR Text Key: 148748407
• Report Number: 8030965-2019-65543
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819650268
• UDI-Public: (01)07611819650268
• 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
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.112S
• Device Lot Number: H721428
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2019
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN
• Patient Outcome(s): Required Intervention