MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.9MM TI LOCKING BOLT 32MM; PIN,FIXATION,SMOOTH

Catalog Number 459.320VS

Device Problem Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

Patient information not available for reporting.Additional product codes: jdw, jds, jdn, hsb.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 europe reports an event in (b)(6) as follows: it was reported that during an unknown surgical procedure on (b)(6) 2018, while the surgeon was attempting to drill at the distal position of the 9mm proximal femoral nail antirotation (pfna) nail, the drill bit interfered with the nail.Surgeon removed the hand piece from the drill bit and struck it slightly with a hammer.The surgeon then attempted to insert a 4.9mm locking bolt, but the bolt went out of bounds.Surgeon then attempted to drill manually but was not successful.Surgery was completed without insertion of the bolt.It was noted that, because of the size of the nail, the clearance between the bone surface and the nail was very thin.Concomitant devices reported: radiolucent insertion handle for trochanteric fixation nails (03.010.405, lot number unknown, quantity 1), 125 degree aiming arm for pfna blade (03.010.406, quantity 1), protection sleeve (356.831, lot number unknown, quantity 1), drill (356.828, lot number unknown, quantity 1).This report is for one (1) 4.9mm locking bolt.This is report 1 of 3 for (b)(4).

• Brand Name: 4.9MM TI LOCKING BOLT 32MM
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7717945
• MDR Text Key: 114954971
• Report Number: 8030965-2018-55253
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07611819702516
• UDI-Public: (01)07611819702516
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K970733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 459.320VS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention