MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN WRIST PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Discomfort (2330); Sleep Dysfunction (2517)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.

Event Description

The end of the drill bit broke off; approximately 1 inch long.He is experiencing problems such as insomnia, redness over radio plate, upper back discomfort.He is not sure if these symptoms are caused by the metal in his wrist.He wants to know the composition of the alloy in the bit used in this type of procedure.He would like to know if stryker manufacturers a part to remove the drill bit.

Manufacturer Narrative

The reported event that the patient is experiencing pain after he had an unknown wrist plate implanted in his wrist, could be confirmed, based on the received medical records of the patient.The review of the medical records indicated that the patient was admitted to the hospital in (b)(6) 2013, with a closed right distal radius fracture, head trauma with a loss of consciousness and rib fracture, after he had fallen from a tree.The patient underwent a right intra-articular distal radius surgery in (b)(6) 2013, and was implanted with 2 plates.As per medical records: ¿in the course of placing the proximal screw, a drill bit broke.It was completely contained within bone.It was felt that retrieving this fragment would cause more trauma allowing the drill bit to remain within the bone.¿ since then the patient has been complaining about tingling to his right median nerve distribution, decreased sensation to the radial border of his ring finger, middle, index and thumb, and decreased range of motion of his wrist.For that reason, the patient attended rehab sessions as he needed continued therapy for range of motion, strengthening and return to function.Since (b)(6) 2014, the patient is fully functional and demonstrates near normal wrist rom in supination and flexion, with some limitations in extension.Since (b)(6) 2015, the patient began having vague and diffuse neurologic complaints, such as vertigo, insomnia, headaches, lower leg muscle fasciculation, more frequent viral illnesses, thoracic spine pain, peripheral neuropathy, restless leg syndrome, microalbuminuria and rashes.The patient had a fairly extensive workout, had metal allergy testing done (which was negative), tested his blood levels of aluminum (which were negative).The patient complained about continued pain and potential removal of the hardware in his wrist, due to possible metal toxicity.The x-rays showed that the distal radius is anatomically reduced, there are no persistent fracture lines, and there is no hardware failure/loosening.Since the actual ¿unknown wrist plate¿ was not returned, and the lot no was not communicated, a visual and manufacturing inspection could not be performed.The actual raw material certificate could not be reviewed because the affected device was not returned and the lot number was not communicated.Nevertheless, in the medical records two different stryker plates are mentioned: ¿ volar smartlock distal radius plate, standard, right,short, 11 holes (54-25386) ¿ lateral distal radius plate, short (54-25400) these implants are made from ti6al4v eli.Regarding the reported complaints the patient is experiencing (insomnia, redness over radio plate, upper back discomfort, etc.), according to the treating physician, ¿his (the patients`) main problem is vague and diffuse neurologic complaints that he feels is related to the metal toxicity from his previous right distal radius hardware.He denies any pain in the right wrist, and his x-rays look excellent.[¿] i advised him that i cannot say for sure whether his neurologic symptoms are or are not related to his previous hardware, but i highly doubt it.¿ as per medical records, the imaging studies (x-rays) were reviewed by the doctor: ¿previous x-rays on his right wrist from (b)(6) 2016 were reviewed.They show volar distal radius and radial styloid plates in place.The distal radius appears anatomically reduced.No persistent fracture lines are seen.No evidence of hardware failure or loosening.¿ it was also stated in the medical records that the patient had a metal allergy testing done, which was negative, and also tested his blood levels of aluminum, which was also negative.The treating surgeon also advised regarding a potential hardware removal: ¿the main problem is that these were titanium plates, and the locking screws will likely be cold-welded to the plate.I advised him that this often requires burring of the screw heads, which will cause significant metal particulate debris within the wound.[¿] after discussion of what will be involved with removing his hardware, he was much less enthusiastic about proceeding.¿ 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

The end of the drill bit broke off; approximately 1 inch long.He is experiencing problems such as insomnia, redness over radio plate, upper back discomfort.He is not sure if these symptoms are caused by the metal in his wrist.He wants to know the composition of the alloy in the bit used in this type of procedure.He would like to know if stryker manufacturers a part to remove the drill bit.

• Brand Name: UNKNOWN WRIST PLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6185208
• MDR Text Key: 62709269
• Report Number: 0008031020-2016-00597
• Device Sequence Number: 1
• Product Code: KXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• 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: 57 YR
• Patient Weight: 73