MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI ELASTIC NAIL 440MM; PIN, FIXATION, SMOOTH

Catalog Number 475.920

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Without a lot number the device history records review could not be completed.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 that on (b)(6) 2020 the patient had an osteosynthesis of the clavicle.On an unknown date, the patient started experiencing unspecified pain.Four weeks after the initial surgery, the patient was seen for follow-up on august 26, 2020 due to the pain.An implant failure was detected in the x-ray.Although the pain decreased after the follow-up, the patient wanted to remove the nail.The implant removal was performed on (b)(6) 2020 , however implant removal could only be done partially, and the lateral part of the broken titanium elastic nail (ten) device remained in the clavicle.No further information was provided.Concomitant devices reported: end cap f/ten ¿1.5-2.5 tan (part# 475.905; lot# 20p0304, quantity: 1).This report is for one (1) 2.0mm ti elastic nail 440mm.This is report 1 of 1 for complaint (b)(4).

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, h6: investigation summary: reviewing attached x-ray, the complaint description can be confirmed that the ten nail is broken off.Investigation site: cq zuchwil.Selected flow: damage.Visual inspection: the investigation of the ten - titanium elastic nail has shown that the tip of nail is broken off.The other side of nail shaft is cut for length adoption.The broken tip of the ten - titanium elastic nail is not available for an further evaluation as reported ( the lateral part of the broken ten remained in the clavicle.) drawing/specification review: as the lot number is unknown we are not able to research the device history record and the manufacturing documents.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.The fracture face is homogenous, which indicates material conformity.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Summary: the complaint is rated as confirmed for this ten nail as the tip is broken.Based on the provided information we are not able to determine the exact cause of this breakage.We can only assume that any occurrence during the healing process, e.G.Non-union, delayed union, mal-union, overloading of the osteosynthesis or a combination of different factors, did lead to a fatigue failure.Or that too much mechanical force on the ten nail had been applied during the surgery, which may weaken the ten nail and lead to premature implant failure.Furthermore we would like to draw your attention to our surgical technique guide, where it is described that: avoid creating a sharp bend which may reduce the effectiveness of the nail.The microscopic view of the broken surface at the returned ten nail part does not show any anomalies of materials structure, which indicates material conformity.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 2.0MM TI ELASTIC NAIL 440MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10985314
• MDR Text Key: 220883927
• Report Number: 8030965-2020-09575
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07611819093027
• UDI-Public: (01)07611819093027
• Combination Product (y/n): N
• PMA/PMN Number: K971783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 475.920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 12/23/2020
• Patient Sequence Number: 1
• Treatment: END CAP F/TEN Ø1.5-2.5 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 90