MAUDE Adverse Event Report: STRYKER TRAUMA KIEL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-3042
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that: a drill bit rupture reference 1320-3042 lot ku78550 occurred during a gamma nail placement.Placement of a 100mm cervical-head screw.Placement of a locking screw.Preparation of the ancillary equipment for distal aiming in static mounting.At this stage of the procedure, the drill bit is broken on the bone.Drilling with the appropriate drill bit.Intraosseous drill bit with no further repercussions is left in place.Positioning of the ancillary for distal aiming in the dynamic montage.Drilling of the drill bit.Placement of a 35 mm cortical screw.A final satisfactory face-profile radiographic check.Abundant washing.Plane by plane closure with skin staples.Bandage.Post-operative instructions: post-operative x-ray to be performed.Recent than icing.Wound care to be performed every 2 days with staples removed on the 15th postoperative day.Sitting and support allowed.Consultation appointment in 6 weeks.Nb: incident during surgery: drill bit broken at the femoral shaft and left in place.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that: "a drill bit rupture reference 1320-3042 lot ku78550 occurred during a gamma nail placement.Placement of a 100mm cervical-head screw.Placement of a locking screw.Preparation of the ancillary equipment for distal aiming in static mounting.At this stage of the procedure, the drill bit is broken on the bone.Drilling with the appropriate drill bit.Intraosseous drill bit with no further repercussions is left in place.Positioning of the ancillary for distal aiming in the dynamic montage.Drilling of the drill bit.Placement of a 35 mm cortical screw.A final satisfactory face-profile radiographic check.Abundant washing.Plane by plane closure with skin staples.Bandage.Post-operative instructions: post-operative x-ray to be performed.Recent than icing.Wound care to be performed every 2 days with staples removed on the 15th postoperative day.Sitting and support allowed.Consultation appointment in 6 weeks.Nb: incident during surgery: drill bit broken at the femoral shaft and left in place." additional information- there was a five minute delay to the procedure.
Additional Manufacturer Narrative
Correction to h6 health impact code.The reported event could be confirmed, since the device was returned for and matches the alleged failure.The device inspection revealed the following: the received drill shows signs of intense usage which is evident from the cutting edges which are blunt and have small dent marks.The drill was found to be broken from the tip region and the broken part was not returned for investigation.From the fractured surface, it can be confirmed that it is a sudden brittle fracture that was caused due to the application of a high bending load.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to being user related.The appearance of breakage surface and cutting edges indicates an intense usage and application of high bending load, leading to a forced brittle fracture.If any additional information is provided, the investigation will be reassessed.

• Brand Name: NA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14739168
• Report Number: 0009610622-2022-00263
• Device Sequence Number: 5596036
• Product Code: LXH
• UDI-Device Identifier: 04546540377883
• UDI-Public: 04546540377883
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: 1320-3042
• Device Catalogue Number: 13203042
• Device Lot Number: KU78550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG