MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 9MM 345MM / STERILE; NAIL, FIXATION, BONE

Model Number	04.043.135S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional 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.D2: additional procode: hwc d9: complainant part is not expected to be returned for manufacturer review/investigation.H6: a manufacturing record evaluation was performed for the finished device.Product code: 04.043.135s-us lot: 866p715 it was electronically reviewed and no non-conformances, manufacturing irregularities were identified during the manufacturing process.The product was released on: june 27, 2022 manufacturing site: jabil bettlach expiry date: may 31, 2032 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 or Problem Description
It was reported that during a procedure on (b)(6)2023, while attempting to drill for proximal locking screws for a tibial nail advanced (tna) nail in the s1 hole, the drill bit hit the nail.The nail was not aligned properly.The surgeon checked the nail for tightness and was able to get a turn to tighten the nail.Surgeon determined that the nail likely misaligned because it became loose from the handle.They were ultimately able to get the drill bit and screw through the nail.Additionally the t-handle chuck seemed to turn freely when it should have been tight.The drill tipped k-wire also was difficult to remove from the inside of the opening drill bit.The surgery was successfully completed with a fifteen minute delay.There was no patient consequence; patient was stable.This report is for a tibial nail-advanced / 9mm 345mm / sterile.This is report 1 of 3 for (b)(4).

• Brand Name: TIBIAL NAIL-ADVANCED / 9MM 345MM / STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17210398
• Report Number: 8030965-2023-08087
• Device Sequence Number: 12183487
• Product Code: JDS
• UDI-Device Identifier: 10886982297631
• UDI-Public: (01)10886982297631
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Model Number: 04.043.135S
• Device Catalogue Number: 04.043.135S
• Device Lot Number: 866P715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AIMING ARM/ RADIOLUCENT; CONNECTING SCREW/ CANNULATED LONG; GUIDE WIRE- W/ DRILL TIP 3.2/ 400; INSERTION HANDLE/ RADIOLUCENT LONG; UNIVERSAL CHUCK WITH T-HANDLE
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 65 KG