MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060085S
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not available to stryker.
Event or Problem Description
This pi is for the gamma3 drill and ball-tipped guide wire (trauma & extremity devices) that was used on the patient during primary surgery while implanting a right hip: it was reported that patient's right hip was revised."patient had an infection and had some components exchanged during the i and d".
Additional Manufacturer Narrative
The reported event that drill, ao small gamma3® ø4.2x300mm was alleged of issue k-111 (infection) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between 0.5 % and 5 %, exceptionally up to 10 % and beyond, mainly depending on the respective surgical procedure and the typical patient population.¿ also, the instruction for use mentions ¿early or late infection, both deep or superficial¿ post operatively as the most frequent adverse effects involving the use of internal fracture fixation devices.The stryker instrument has been delivered in sterile condition.A respective statement concerning contamination of sterile stryker devices is attached.In the case of a clinically manifest infection, in which any sterile packed stryker device was involved, dqf 13-003 shall be filled by the hospital (or exceptionally by the sales rep) due to formal reasons.If there are no obvious events, which may be caused in the field of responsibility of stryker, stryker shall decline all responsibility in general because the probability that a contamination of the sterile packed devices has been caused in stryker¿s sphere of influence is negligible.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition is unknown.
Event or Problem Description
This pi is for the gamma3 drill and ball-tipped guide wire (trauma & extremity devices) that was used on the patient during primary surgery while implanting a right hip: it was reported that patient's right hip was revised."patient had an infection and had some components exchanged during the i and d".

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7612014
• Report Number: 0009610622-2018-00245
• Device Sequence Number: 2195317
• Product Code: LXH
• UDI-Device Identifier: 04546540195937
• UDI-Public: 04546540195937
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 18060085S
• Device Lot Number: K030A7C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR