MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO SMALL GAMMA3® Ø4.2X300MM; 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	05/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "on (b)(6) 2022 during a gamma nail implant operation, the surgeon, while he proceeded to drill the bone through the static hole - instruments: aiming arm of the stryker gamma3 kit product code 1320-0100 and drills product code 1320-3042, was found to impact against the intramedullary nail expecting instead to have obtained full centering on the through hole of the nail, consequently breaking the tip of the drill.He then proceeded to remove every metal fragment and continued milling with a second cutter, this time passing through the dynamic hole, but the event was repeated the same as above, leading to the breakage of the second cutter as well; in this instance, however, it was not possible for him to recover all the metal fragments (one or more remained stuck in the cortex), and consequently the patient will undergo further surgery.".
Event or Problem Description
As reported: "on (b)(6) 2022 during a gamma nail implant operation, the surgeon, while he proceeded to drill the bone through the static hole - instruments: aiming arm of the stryker gamma3 kit product code 1320-0100 and drills product code 1320-3042, was found to impact against the intramedullary nail expecting instead to have obtained full centering on the through hole of the nail, consequently breaking the tip of the drill.He then proceeded to remove every metal fragment and continued milling with a second cutter, this time passing through the dynamic hole, but the event was repeated the same as above, leading to the breakage of the second cutter as well; in this instance, however, it was not possible for him to recover all the metal fragments (one or more remained stuck in the cortex), and consequently the patient will undergo further surgery.".
Additional Manufacturer Narrative
Please note correction to h6 health impact code.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Despite several attempts neither further details were provided nor the item[s] in question were made available [drills already disposed/counterpart not returned] and thus, a physical evaluation was impossible and limited to information available, only.Known from previous cases and due to the fact that nothing was reported during the pre-operative check, which is required per ifu, the case is rather related to a sub-optimal intraoperative procedure [contact with a hard metal object due to alleged guidance inaccuracy of counterpart], which is supported by the event description ¿drills product code 1320-3042, was found to impact against the intramedullary nail expecting instead to have obtained full centering on the through hole of the nail, consequently breaking the tip of the drill¿ however, based on details provided an exact root cause could not be determined and due to non-available item a thorough investigation with a technical statement impossible.Broken drills, with remaining parts in patient, are known from previous cases and were evaluated by a medical expert.Excerpts from the clinical assessment in a similar case ¿ reconfirmed by hcp: ¿an intra-operative breakage of a drill is a rare but common complication and well known to an experienced user.It is caused by twisting the drill and too much bending.Breakage caused by material defect is very rare in current manufacturing technology.It is of interest whether a broken part of a drill can be left in the bone or should be retrieved; also in the case that greater harm to the bone would be done.It is well known to an expert user that a broken part of a drill which is completely embedded in the bone normally does not cause any harm.In absence of a nickel allergy, the material used for the drill does not cause any local or systemic incompatibility.[¿] therefore, no further surgical procedures in this special case are required¿.However, it lies in the responsibility of the treating surgeon to leave or to remove the broken off part.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: DRILL, AO SMALL GAMMA3® Ø4.2X300MM
• 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: 14985166
• Report Number: 0009610622-2022-00324
• Device Sequence Number: 1584342
• Product Code: LXH
• UDI-Device Identifier: 04546540377883
• UDI-Public: 04546540377883
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown