MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number	04.005.526S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2021, there was a issue inserting the 5mm distal locking screw with a short trochanteric fixation nail-advanced (tfna) nail.The 5mm distal locking screw screw missed the hole in the tfna nail and was not able to be removed.The screw was fixed in the bone.They are unsure if the aiming arm had loosened during the procedure.With this particular complaint there is no implants to return as all elements of the construct have remained implanted in the patient.There was a surgical delay of one (1) hour thirty (30) minutes.The procedure was successfully completed.No further information provided.Concomitant device reported: aiming arm (part# unknown; lot# unknown; quantity: 1); tfna fem nail ø11 r 130° l235 timo15 (part # 04.037.144s, lot # 51p7275, quantity 1); tfna scr perf l110 tan (part # 04.038.210s, lot # unknown, quantity 1).This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 36mm f/im nail-ster.This is report 2 of 2 for complaint (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11375366
• Report Number: 8030965-2021-01324
• Device Sequence Number: 3781349
• Product Code: HWC
• UDI-Device Identifier: 10886982085955
• UDI-Public: (01)10886982085955
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2021

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: 04.005.526S
• Device Catalogue Number: 04.005.526S
• Device Lot Number: 892576
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/24/2021
• Patient Sequence Number: 1