MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

Device Problem Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plate/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn.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, the investigation will be updated as applicable.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 a patient underwent an explantation surgery on (b)(6) 2018.The patient was initially implanted with a variable angle-locking compression plate (va-lcp) on (b)(6) 2018 to treat a distal radius fractures.During the procedure, the surgeon tried to remove two (2) broken locking screws, however, the heads of the screws had been locked in the plate, a hollow reamer nor an extraction screw could not be used.Thus, the surgeon gave up removing the shafts of broken screws, and decided to leave the plate and screws inside the patient.There was no plan of reoperation.However, if irritation symptoms of the flexor tendon appear, it will be removed.The procedure was successfully completed.The surgery was delayed by more than 30 minutes.Patient outcome was unknown.  this report is for one (1) unknown plate.Concomitant devices reported:  2.4mm variable angle locking screw l18mm (part #: 04.210.118s, lot #: l667991, quantity unknown).This complaint involves three (3) devices.This report is 3 of 3 for (b)(4).

Event Description

This complaint (b)(4) captures all intra-operative events while pc-000332559 captures post-operative breakage of screw event.Concomitant devices: 2.4mm variable angle locking screw l18mm (part #: 04.210.118s, lot #: l667991, quantity unknown) 2.4mm variable angle locking screws l14mm (part #: 04.210.114s, lot #: l298947, quantity: 1).2.7 mm cortex screws l14mm (part #: 402.874s, lot #: l615450, quantity: 1).2.7 mm cortex screws l18mm (part #: 402.878s, lot #: l399720, quantity: 1).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Updated concomitant devices.Device remained in the patient.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.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8157514
• MDR Text Key: 130174584
• Report Number: 8030965-2018-58969
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• 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: 11/21/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 01/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention