MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: LOCKING; SCREW, FIXATION, BONE

Catalog Number UNK - SCREWS: LOCKING: TRAUMA

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for one unknown - screws: locking: trauma part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Unknown if complainant device is 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 (b)(4) reports an event in (b)(6) as follows: it was reported that on an unknown date, that a patient underwent implant surgery for the proximal tibial fracture with the two screws in question.On (b)(6) 2021, the patient underwent the removal surgery because bone union was confirmed.At that time, the surgeon found that two locking screws had been broken.He used a special extraction device, and the operation was completed without any internal residue and any surgical delay.No further information is available.Concomitant device reported: unknown plates: tibia (part# unknown; lot# unknown; quantity: 1).This complaint involves two devices.This report is for one unk - screws: locking.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Product complaint #: (b)(4).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.H10 additional narrative: d9: complainant device is not expected to be returned for manufacturer review/investigation.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - SCREWS: LOCKING
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11334814
• MDR Text Key: 239062351
• Report Number: 8030965-2021-01034
• Device Sequence Number: 1
• Product Code: HWC
• 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: 01/27/2021

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: UNK - SCREWS: LOCKING: TRAUMA
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 04/22/2021
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: TIBIA.; UNK - SCREWS: LOCKING.; UNK - SCREWS: LOCKING.
• Patient Outcome(s): Required Intervention