MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problems Fracture (1260); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device disposition is unknown.

Event Description

It was reported by the customer service (b)(4), that mr.(b)(6) called about a surgery regarding his sister in law (approx.(b)(6) years old) has undergone at the (b)(6) in (b)(6) 2017 involving the stryker gamma nail.In (b)(6) 2017, she had to undergo surgery again as there was a fracture (unclear if it was a fracture of the gamma nail or the bone).In 2018 she had another surgery (separate (b)(4)).It was indicated that the initial call was to ask what the warranty is for a gamma nail.He was told that he needs to contact the hospital and that the hospital then can contact stryker if there would be an issue with one of our products.He understood that they are in discussion with the hospital as they think it is a medical error.The legal advisor of the hospital they have contact with is mr.(b)(4).

• Brand Name: UNKNOWN GAMMA NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7607220
• MDR Text Key: 111296635
• Report Number: 0009610622-2018-00243
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR