MAUDE Adverse Event Report: SYNTHES (USA); SCREW,FIXATION,BONE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown quantity of unknown screws.Part and lot numbers are unknown; udi number is unknown.Implant date reported as on or about (b)(6) 2013.Device was not reported to be 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.(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

It was reported that a patient underwent an implantation on his left wrist with a synthes' short bend plate and corresponding screws to aid in his wrist fusion on or around (b)(6) 2013.The devices subsequently failed and caused severe injuries to the patient, who didn't discover the failures until about (b)(6) 2016.No other information was provided.This report is for unknown quantity of unknown screw.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Patient information provided.Update.Date of implant.Date of explant is not known.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

A photograph of the complained device was received.Therefore, a revision procedure has occurred on an unknown date.

Manufacturer Narrative

Customer quality (cq) engineering investigation/summary: it was reported that a patient underwent an implantation on his left wrist with a synthes' short bend plate and corresponding screws to aid in his wrist fusion on or around (b)(6) 2013.The devices subsequently failed and caused severe injuries to the patient, who didn't discover the failures until about (b)(6) 2016.No other information was provided.A photo of complained device received, therefore a revision occurred on an unknown date.This complaint is confirmed for one unknown screw.The provided photos in the complaint file show visual evidence of one broken unknown screw.It is unknown whether the screw broke post-operatively or during explanations.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition.There are 4 in-tact screws shown in the provided photo.No allegations were reported against these screws.Visual inspection of the provided photo shows no indication that these screws caused or contributed to this complaint event, and therefore no further investigation will be performed for these screws.No new malfunctions were identified because of the investigation.Based on the information available, this complaint will be accounted for and monitored via post market 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.

• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6792729
• MDR Text Key: 82652955
• Report Number: 2520274-2017-12089
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR