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

Catalog Number 459.400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional procode: jdw, jds, jdn, hsb.Implant date: date of implantation is an unknown date in (b)(6) 2017.Device evaluated by mfr: the device was received, the investigation is in progress, 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2018, the patient underwent a removal procedure due to pseudoarthrosis.Patient was initially implanted with a titanium (ti) cannulated trochanteric fixation nail (tfn), femoral neck screw, and locking bolt to treat a trochanteric breakage in (b)(6) 2017.A surgical delay of unknown duration occurred.Patient status is unknown.This report is for a 4.9mm ti locking bolt 40mm.This is report 3 of 3 for (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.Received device was visually inspected and no defect were found which might be leading to reported condition.Overall surface wear was present due to removal process.No defects were found during investigation which would contribute to the event.During the investigation, no product design and manufacturing issues or discrepancies were observed that may have contributed to the event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: part: 459.400, lot: 5941577, manufacturing site: salzburg, release to warehouse date: 12.Jan.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 4.9MM TI LOCKING BOLT 40MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8457737
• MDR Text Key: 140063967
• Report Number: 8030965-2019-62290
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07611819043145
• UDI-Public: (01)07611819043145
• Combination Product (y/n): N
• PMA/PMN Number: K970733
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 459.400
• Device Lot Number: 5941577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention