MAUDE Adverse Event Report: SYNTHES USA; NAIL,FIXATION,BONE

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Patient¿s weight is not provided for reporting.This report is for one (1) unknown 12 mm x 315 mm universal tibia (slotted) nail.Part and lot numbers were unknown.Without the specific part and lot number, the udi is not available.Implanted many years before the revision surgery, approximately 20-30 years ago; exact date is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.The (510k): unknown, as specific part and lot numbers for nail is not provided.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

Itit was reported that a patient underwent a hardware removal and revision surgery on (b)(6) 2017 due to recent left tibia plateau fracture.In order to repair this recent fracture, an old tibia universal nail first had to be removed (the patient underwent a repair of a tibia midshaft fracture on an unknown date many years before, approximately 20-30 years ago).Removed hardware included one unknown 12 mm x 315 mm universal tibia (slotted) nail.During the removal, the top of the nail broke off.The piece of nail came out with the extractor still attached to it.The remainder of the nail remains in the bone.The fracture extended two inches from the top of the tibia.The surgeon was able to implant a four-hole left 3.5 mm variable angle locking compression (va lcp) proximal tibia plate and eight-nine screws to fix the fracture.There were no reported surgical delays, no additional x-rays or medical intervention necessary.The procedure was completed successfully with the patient in stable condition.Concomitant device reported: extractor (quantity 1).This report addresses the nail that broke during the revision surgery.The revision surgery due to recent left tibia plateau fracture has been reported under the linked complaint (b)(4).This report is for one (1) unknown 12 mm x 315 mm universal tibia (slotted) nail.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Part of the nail remained in the patient¿s bone; device not considered explanted.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.

Manufacturer Narrative

The reported unknown tibia nail (part number unknown / lot number unknown) was not received for investigation.The investigation was based exclusively on the reported information and provided pictures.An inspection of the provided picture was performed.The complaint condition is confirmed.The nail is shown in the provided pictures with a roughly transverse break below two oblong proximal locking holes.The reminder of the nail is not shown and is reported to remain in the patient.No part number or lot number was observed.No definitive root cause could be determined as circumstances surrounding the event and the forces encountered over the approximate 20 to 30 years of implant are unknown.During the review, no product issues were observed that may have contributed to the complaint condition.No new malfunctions were observed during this investigation.Replication of the complaint condition is not applicable as the device is already broken and was not returned for evaluation.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: NAIL,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: 6785955
• MDR Text Key: 83136043
• Report Number: 2520274-2017-12078
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/10/2017
• Supplement Dates Manufacturer Received: 08/11/2017; 09/13/2017
• Supplement Dates FDA Received: 08/11/2017; 09/13/2017
• 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 Age: 52 YR