MAUDE Adverse Event Report: STRYKER GMBH NON LOCKING SCREW ANCHORAGE Ø3.0MM / L24MM; PLATE, FIXATION, BONE

Catalog Number PLSS3024S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Failure of Implant (1924); Pain (1994); Local Reaction (2035); Swelling (2091); No Code Available (3191)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.

Event Description

The patient reported that she has an operation for a bunion on (b)(6) 2017 and that following surgery her metatarsal snapped.The patient further reported that the surgeon then implanted a stryker device on approximately (b)(6) 2017 to treat the fractured metatarsal and that a 'template' was implanted in error which subsequently dug into the bone and caused local tissue reactions.The patient further reported that she required revision surgery, which was carried out on (b)(6) 2017, for the template to be removed and affected tissues debrided.The customer would like to know the composition of the material from which the template is made.The patient reported that she had pain and swelling during the period the plate was in place.

Manufacturer Narrative

This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

Event Description

The patient reported that she has an operation for a bunion on (b)(6) 2017 and that following surgery her metatarsal snapped.The patient further reported that the surgeon then implanted a stryker device on approximately (b)(6) 2017 to treat the fractured metatarsal and that a 'template' was implanted in in error which subsequently dug into the bone and caused local tissue reactions.The patient further reported that she required revision surgery, which was carried out on (b)(6) 2017, for the template to be removed and affected tissues debrided.The customer would like to know the composition of the material from which the template is made.The patient reported that she had pain and swelling during the period the plate was in place.

• Brand Name: NON LOCKING SCREW ANCHORAGE Ø3.0MM / L24MM
• Type of Device: PLATE, FIXATION, BONE
• 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: 6913412
• MDR Text Key: 88115380
• Report Number: 0008031020-2017-00567
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K083447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PLSS3024S
• Device Lot Number: F14863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2017
• Initial Date FDA Received: 10/04/2017
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 10/17/2017
• 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