MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTS_PRODUCT; TOURNIQUET, PNEUMATIC

Catalog Number UNK_INS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Date 07/08/2013

Event Type  Injury  

Manufacturer Narrative

In the legal case the nerve damaged is noted to be the perineal nerve.Based on the description of the location of the nerve, it is most likely referring to the peroneal nerve.Legal case.

Event Description

On or about (b)(6), 2015, stryker received a personal injury lawsuit alleging that an automated tourniquet system was used during a total knee replacement surgery.It is further alleged that, upon waking from the operation, the patient almost immediately noticed that he had no sensation or motor control below the left knee.The patient had no control over his left foot and could not hold his toe up.The lawsuit alleges that the patient has damage to the perineal nerve.The lawsuit alleges that to date, the patient has limited feeling in his lower left leg and has regained minimal control over his foot.Stryker is unable to ascertain whether or not one of its products was actually used.The lawsuit identifies multiple possible device manufacturers.The tourniquet was elevated to 300 mmhg for 58 minutes.

• Brand Name: UNKNOWN_INSTRUMENTS_PRODUCT
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5003185
• MDR Text Key: 22951385
• Report Number: 0001811755-2015-02921
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_INS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability